Dr Falk 
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38 Trials

   

Trial + Data / EventsStatusPhNRegionInterventionsSponsorConditionsPrimary complStudy compl
RhuDex (AV 1142742) / Dr Falk, Medigene
2020-001961-34: Clinical trial comparing the efficacy and safety of Rhudex granules with placebo in the treatment of the liver disease Primary Biliary Cholangitis

Ongoing
2
136
Europe
RhuDex 25 mg (31.75 mg RhuDex choline salt) granules, RhuDex 50 mg (63.5 mg RhuDex choline salt) granules, RhuDex 100 mg (127 mg RhuDex choline salt) granules, Granules
Dr. Falk Pharma GmbH, Dr. Falk Pharma GmbH
Primary biliary cholangitis, A type of long-term liver disease in which the bile ducts in the liver become damaged., Diseases [C] - Immune System Diseases [C20]
 
 
budesonide rectal foam / Generic mfg.
2009-015077-12: The use of corticosteroids (Budenofalk) as a chemopreventative agent in ulcerative colitis associated neoplasia

Ongoing
4
50
Europe
Budenofalk rectal foam, Budenofalk 2mg rectal foam, Budenofalk 2mg rectal foam
University Hospital Birmingham NHS Foundation Trust
chronic ulcerative colitis
 
 
NCT05976802: Dose Ranging Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Budesonide Rectal Foam in Pediatric Patients Aged 5 to 17 Years With Active, Mild to Moderate Distal Ulcerative Colitis

Not yet recruiting
4
100
NA
High dose budesonide rectal foam, Low dose budesonide rectal foam, Matching placebo rectal foam
Bausch Health Americas, Inc.
Ulcerative Colitis
06/25
06/25
2016-001921-15: Novel budesonide suppository vs. budesonide foam in acute ulcerative proctitis.

Ongoing
3
576
Europe
Budenofalk® suppositories (BUS), Budenofalk® 2 mg foam, Suppository, Rectal foam, Budenofalk® 2 mg foam
Dr. Falk Pharma GmbH, Dr. Falk Pharma GmbH
Acute Ulcerative Proctitis, Acute Ulcerative Proctitis - Inflammation of the Rectum, Diseases [C] - Digestive System Diseases [C06]
 
 
Budenofalk (budesonide gastro-resistant) / Dr Falk
2019-003334-16: Novel budenosid suppository in addition to basic therapy with oral mesalazine compared to basic therapy alone for treatment of ulcerative colitis

Not yet recruiting
3
360
Europe, RoW
Budenofalk® suppositories, Salofalk 3g gastro-resistant prolonged-release granules, Suppository, Gastro-resistant granules, Salofalk 3g gastro-resistant prolonged-release granules
Dr. Falk Pharma GmbH, Dr. Falk Pharma GmbH
acute ulcerative colitis, acute ulcerative colitis - inflammation and ulcers of the colon and rectum, Diseases [C] - Digestive System Diseases [C06]
 
 
NCT04921033: Exclusive Enteral Nutrition in Patients With Ileocaecal Crohn's Disease

Recruiting
3
256
RoW
EEN (Nestle Modulen®), Standart of care, Budesonide (Budenofalk®), Prednisolone (Deltacortril®), Azathioprine (Imuran®)
Duzce University
Crohn Disease, Nutrient; Excess, Remission/Regression
01/26
01/26
2019-003271-19: The influence of the body on the fate of budesonide in healthy volunteers de lichamelijke invloed op de vrijzetting van budesonide in gezonde vrijwilligers

Not yet recruiting
2
10
Europe
Budesonide Ferring, Budenofalk, Entocort, Nexiam, Tablet, Capsule, Capsule, hard
KU Leuven, KU Leuven
Healthy volunteers gezonde vrijwilligers, Healthy volunteers gezonde vrijwilligers, Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]
 
 
NCT06922305: Relative Bioavailability Study of HR19042 in Healthy Subjects

Completed
1
18
RoW
HR19042 Capsule, Tarpeyo®, Budenofalk®
Jiangsu HengRui Medicine Co., Ltd.
Primary IgA Nephropathy; Autoimmune Hepatitis
01/24
01/24
Salofalk suppository (mesalazine rectal suppository) / Dr Falk
ChiCTR2000028869: phase IIa clinical trial of Colitis Suppositories

Recruiting
2
60
 
Colitis Suppositories, one at a time, twice a day, in the early and late anal plug into the rectum. ;Mesalazine Suppositories, one at a time, twice a day, in the early and late anal plug into the rectum.
Beijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University; Shandong Kangzhonghong Medical Technology Development Co. Ltd., Self-financing and national project funding
mild-to-moderate active ulcerative colitis (Qi-Deficiency and Blood-Stasis Syndrome)
 
 
Budenofalk granules (budesonide gastro-resistant granules) / Dr Falk
ChiCTR2000039057: Clinical study of Wenshen Yiqi Granules in improving airway hypersecretion in patients with chronic obstructive pulmonary disease

Recruiting
4
60
 
Wenshen Yiqi Granules+ Tiotropium Bromide Powder Inhalation ;Tiotropium Bromide Powder Inhalation ;Wenshen Yiqi Granules+ Tiotropium Bromide Powder Inhalation+Budesonide formoterol inhalation powder ;Tiotropium Bromide Powder Inhalation+Budesonide formoterol inhalation powder
The Second Affiliated Hospital of Zhejiang Chinese Medical University; The Second Affiliated Hospital of Zhejiang Chinese Medical University, Zhejiang Administration of traditional Chinese Medicine
COPD
 
 
ChiCTR2000032826: Effect of Yinqiao Qingyan Granules in treating the acute bronchitis infected by respiratory syncytial virus in children

Not yet recruiting
N/A
120
 
Ribavirin granule was given orally and budesonide-solution was inhaled ;Yinqiao Qingyan granule was given orally
Guangdong Secondary Hospital of Traditional Chinese Medicine; Guangdong Secondary Hospital of Traditional Chinese Medicine, Scientific research project of guangdong administration of traditional Chinese medicine
Acute bronchitis infected by respiratory syncytial virus
 
 
ChiCTR2200061471: Randomized multicenter clinical evaluation of Xiaoer Dingchuan Granule in the intervention of respiratory syncytial virus pneumonia in children (phlegm-heat blocking lung syndrome)

Not yet recruiting
N/A
240
 
Xiaoer Dingchuan Granule combined with glucocorticoid budesonide suspension ;Glucocorticoid budesonide suspension
The Affiliated Hospital of Liaoning University of Traditional Chinese Medicine; The Affiliated Hospital of Liaoning University of Traditional Chinese Medicine, Pediatric Pneumonia Inheritance and Innovation Platform Construction Project (2020-1)
Respiratory syncytial virus pneumonia in children
 
 
ChiCTR2400083789: Clinical and mechanism study of Zhijing decoction on inhibiting airway remodeling of chronic persistent severe asthma by inhibiting ferroptosis

Not yet recruiting
N/A
60
 
budesonide/formoterol powder inhalation 320μg/9μg, batch number: H20140458 (AstraZeneca AB), one inhalation three times daily.; budesonide/formoterol powder inhalation 320μg/9μg, batch number: H20140458 (AstraZeneca AB), one inhalation three times daily.zhijing decoction(Centipede 3g, Scorpion 3g, Sichuan New Green Pharmaceutical Technology Development Co., LTD. Formula granules)
Shanghai Municipal Hospital of Traditional Chinese Medicine; Shanghai Municipal Hospital of Traditional Chinese Medicine, self-financing
asthma
 
 
Salofalk (mesalazine) / Dr Falk
2019-001009-26: Gastrointestinal behaviour of mesalazine in healthy volunteers Gastrointestinaal gedrag van mesalazine in gezonde vrijwilligers

Not yet recruiting
4
10
Europe
Modified-release tablet, Gastro-resistant tablet, Pentasa 500 mg tabletten met verlengde afgifte, Claversal 500 mg maagsapresistente tabletten, Mezavant 1.2 g maagsapresistente tabletten met verlengde afgifte, Nexiam, 40 mg Maagsap-resistente tabletten
KU Leuven - Drug Delivery and Disposition, KU Leuven
Healthy volunteers Gezonde vrijwilligers, Healthy volunteers Gezonde vrijwilligers, Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]
 
 
2022-001683-10: Describe the level of remission (illness is no longer active, is under control) in patients with ulcerative colitis who are treated with 5-ASA medication Beschrijven van de mate van remissie (ziekte is niet langer actief, is onder controle) bij patiënten met ulceratieve colitis, die behandeld worden met 5-ASA medicatie. Décrire le degré de rémission (la maladie n'est plus active, elle est sous contrôle) chez les patients atteints de colite ulcéreuse traités par des médicaments 5-ASA.

Not yet recruiting
4
200
Europe
Gastro-resistant tablet, Suppository, Rectal foam, Gastro-resistant granules for oral suspension in sachet, Tablet, Granules for oral solution in sachet, Rectal suspension, Claversal, Colitofalk, Pentasa, Mezavant, Mesalazine Teva, Salazopyrine
BIRD vzw (Belgian IBD Research and Development), BIRD vzw, Ferring N.V.
Ulcerative colitis Ulceratieve colitis Colite Ulcéreuse, Chronic inflammation of the large bowel Chronische ontsteking van de dikke darm Inflammation chronique du côlon, Diseases [C] - Digestive System Diseases [C06]
 
 
Salofalk prolonged-release granules (mesalazine gastro-resistant prolonged-release granules) / Dr Falk
2006-006198-26: Mechanistic randomised contorlled trial of Mesalazine in symptomatic diverticular disease

Ongoing
4
40
Europe
Mesalazine, Salofalk 1000mg granules, Salofalk 1000mg granules
University of Nottingham
Symptomatic diverticular disease defines as patients with recurrent abdominal pain on more then 3 days per month with proven diverticula.
 
 
Aemcolo (rifamycin SV MMX) / Cosmo Pharma, RedHill, Dr Falk
NCT04501380: Efficacy of AEMCOLO (Rifamycin SV MMX) in the Treatment of Small Intestinal Bacterial Overgrowth (SIBO)

Enrolling by invitation
2
30
US
AEMCOLO (Rifamycin SV MMX)
Bradley Connor
Small Intestinal Bacterial Overgrowth, Gastrointestinal Disease, Gastrointestinal Infection
12/22
12/22
RIVET, NCT04082780: Rifamycin in Minimal Hepatic Encephalopathy

Completed
2
30
US
Rifamycin SV MMX, Aemcolo, Placebo
Hunter Holmes Mcguire Veteran Affairs Medical Center
Hepatic Encephalopathy, Cirrhosis, Liver
04/23
04/23
NCT04027894: Study to Evaluate Safety and Efficacy of Rifamycin SV MMX in Treating Traveler's Diarrhea in Children Age 12 to 17 Years

Not yet recruiting
2
142
NA
Rifamycin SV MMX, Rifamycin, Placebo to Rifamycin SV-MMX, Placebo
RedHill Biopharma Limited
Traveler's Diarrhea
01/25
12/25
NCT04026984: Evaluate Safety and Efficacy of Rifamycin SV MMX in the Treatment of Traveler's Diarrhea in Children Age 6 to 11 Years

Not yet recruiting
2
142
NA
Rifamycin SV-MMX, Rifamycin, Placebo
RedHill Biopharma Limited
Traveler's Diarrhea
06/25
12/25
Jorveza (budesonide orodispersible tablets) / Dr Falk
2020-002593-27: Budesonide as a treatment for inflammation in stomach complaints. Budesonide als behandeling voor ontstekingsreacties bij maagklachten.

Not yet recruiting
4
36
Europe
Budesonide, Capsule, Jorveza
UZ Leuven, KU Leuven
Functional dyspepsia Functionele dyspepsie, Chronic stomach disease Chronische maagklachten, Diseases [C] - Digestive System Diseases [C06]
 
 
2020-001314-37: clinical study to show equal clinical efficacy of two dosing regimen of budesonid orodispersible tablets (twice daily vs. once daily) for treatment of inflammation of the esophagus

Not yet recruiting
3
242
Europe
Budesonide 2 mg orodispersible tablets (BUL 2 mg), Budesonide 1 mg orodispersible tablets (BUL 1 mg), Orodispersible tablet, Jorveza
Dr. Falk Pharma GmbH, Dr. Falk Pharma GmbH
eosinophilic esophagitis Eosinophile Ösophagitis, allergy-like, chronic inflammation of the esophagus allergieartige, chronische Entzündung der Speiseröhre, Diseases [C] - Digestive System Diseases [C06]
 
 
2017-003516-39: A phase III clinical study in adult and adolescent patients with eosinophilic inflammation of the gullet to prove superiority compared to placebo of an episodic and/or a continuous 48-week treatment with budesonide orodispersible tablets for maintaining remission Klinische Studie der Phase III mit erwachsenen und jugendlichen Patienten mit eosinophiler Entzündung der Speiseröhre zum Nachweis der Überlegenheit einer 48-wöchigen Behandlung in Episoden und/oder fortlaufend mit Budesonid Schmelztabletten im Vergleich zu Plazebo zur Aufrechterhaltung einer Remission.

Ongoing
3
110
Europe
Budesonide 1 mg orodispersible tablets, Budesonide 0.5 mg orodispersible tablets, BUL 1 mg, BUL 0.5 mg, Orodispersible tablet, Jorveza 1 mg orodispersible tablets, Jorveza 0.5 mg orodispersible tablets
Dr. Falk Pharma GmbH, DR. FALK PHARMA GMBH, Dr. Falk Pharma GmbH, DR. FALK PHARMA GmbH
Maintenance of remission in eosinophilic esophagitis Remissionserhalt der eosinophilen Ösophagitis, Chronic allergic/immune-mediated inflammatory disease of the gullet in its remission phase Chronisch allergische/immun-vermittelte entzündliche Erkrankung der Speiseröhre in ihrer Remissionsphase, Diseases [C] - Digestive System Diseases [C06]
 
 
EOS-4, NCT06596252 / 2020-001314-37: Once Daily Versus Twice Daily Budesonide Orodispersible Tablets for Induction of Remission in EoE

Recruiting
3
308
Europe, US
Budesonide
Dr. Falk Pharma GmbH, Dr. Falk Pharma GmbH
Eosinophilic Esophagitis
08/25
09/25
2018-002617-35: Double-blinded (treatment group unknown to physician and patient), randomised (treatment group allocated by chance) phase II trial on the efficacy and tolerability of an 8 week treatment with two different doses of budesonide tablets dissolving in the mouth compared to placebo (medication without active substance), for prevention of constrictions of the oesophagus in adult patients after removal of cancer tissue using an endoscopic surgery technique Doppelt verblindete (weder Arzt noch Patient kennen die Behandlungsgruppe), randomisierte (Behandlungsgruppe per Zufallsprinzip) Phase II Studie zur Wirksamkeit und Verträglichkeit einer 8-wöchigen Behandlung zweier Dosierungen einer sich im Mund auflösenden Budesonid-Tablette im Vergleich zu Plazebo (Scheinmedikament), zur Verhinderung von Verengungen der Speiseröhre bei erwachsenen Patienten nach Entfernung von Speiseröhrenkrebsgewebe mit Hilfe einer endoskopischen Operationstechnik

Not yet recruiting
2
90
Europe
2 mg budesonide orodispersible tablet, BUL 2 mg, Orodispersible tablet, Jorveza 1 mg orodispersible tablets
Dr. Falk Pharma GmbH, Dr. Falk Pharma GmbH
Prevention of oesophageal strictures in adult patients after endoscopic submucosal dissection Verhinderung von Strikturen der Speiseröhre bei erwachsenen Patienten nach endoskopischer Submukosadissektion, Prevention of strictures of the oesophagus in adult patients after removal of cancer tissue from the oesophagus using an endoscopic surgery technique Verhinderung von Verengungen der Speiseröhre bei erwachsenen Patienten, bei denen Gewebe eines Speiseröhrenkrebs mit Hilfe einer endoskopischen Operationstechnik entfernt wurde, Diseases [C] - Digestive System Diseases [C06]
 
 
Switch, NCT05594849: Evaluation of Efficacy, Safety and Patient' Satisfaction of Therapeutic From Off-Steroids to Budesonide

Completed
N/A
31
Europe
Budesonide Orodispersible Tablets (Jorveza)
Istituto Clinico Humanitas
Eosinophilic Esophagitis
10/23
10/23
norucholic acid (norUDCA) / Dr Falk
2016-003367-19: A study to compare norursodeoxycholic acid with placebo in the treatment of primary sclerosing cholangitis

Ongoing
3
300
Europe, RoW
Norursodeoxycholic acid, [NorUDCA], Capsule
Dr. Falk Pharma GmbH, DR. FALK PHARMA GMBH, Dr. Falk Pharma GmbH,
Primary Sclerosing Cholangitis (PSC) is a slowly progressing chronic cholestatic liver disease of assumed autoimmune, but finally unidentified etiology, characterized by a chronic inflammatory and fibro-obliterative destruction of extra-, and intrahepatic bile ducts. The disease is characterized by diffuse inflammation, fibrosis, and strictures of the intra- and/or extrahepatic bile ducts with an impaired biliary secretion of potentially aggressive bile fluid often leading to cirrhosis., Primary Sclerosing Cholangitis (PSC) is a slowly progressing chronic liver disease characterized by changes in the gall ducts inside and/or outside the liver, such as narrowing or enlargement., Diseases [C] - Digestive System Diseases [C06]
 
 
NCT03872921: norUrsodeoxycholic Acid vs Placebo in PSC

Active, not recruiting
3
303
Europe
norUrsodeoxycholic Acid, NUC
Dr. Falk Pharma GmbH
Primary Sclerosing Cholangitis
01/25
06/26
NCT06886360: Study with Norucholic Acid Tablets in Patients with Primary Sclerosing Cholangitis (PSC)

Not yet recruiting
3
120
NA
norucholic acid
Dr. Falk Pharma GmbH
Primary Sclerosing Cholangitis
09/27
09/27
2013-004605-38: Clinical trial comparing different doses of norursodeoxycholic acid capsules with placebo in the treatment of non-alcoholic fatty liver disease Klinische Studie welche zwei verschiedene Konzentrationen von Norursodeoxycholsäure Kapseln mit Placebo in der Behandlung der nicht alkoholischen Fettleber vergleicht

Ongoing
2
156
Europe
Norursodeoxycholic acid, norUDCA,
Dr. Falk Pharma GmbH, Dr. Falk Pharma GmbH
Non-alcoholic fatty liver disease (NAFLD)
 
 
2021-001431-56: Clinical study comparing two doses of norucholic acid against placebo in the treatment of a liver disease called primary biliary cholangitis in patients without sufficient response to ursodeoxycholic acid

Ongoing
2
90
Europe
Norucholic acid (NCA) 500 mg, NCA 500mg, Film-coated tablet
Dr. Falk Pharma GmbH, Dr. Falk Pharma GmbH
primary biliary cholangitis, Primary biliary cholangitis is a rare chronic liver disease, Diseases [C] - Digestive System Diseases [C06]
 
 
NCT05083390 / 2018-003443-31: Norursodeoxycholic Acid vs. Placebo in NASH

Recruiting
2
363
Europe
norUrsodeoxycholic acid, norucholic acid, norUDCA, NCA
Dr. Falk Pharma GmbH, Dr. Falk Pharma GmbH,
Nonalcoholic Steatohepatitis
01/25
04/25
TAK-227 / Takeda
2017-002241-30: Clinical trial with ZED1227 capsules compared to placebo in subjects with celiac disease during a 6-week treatment. Klinikinis tyrimas su tiriamuoju vaistiniu preparatu (TVP) ZED1227 kapsulės, lyginant jį su placebu (jo sudėtyje nėra veikliosios medžiagos), pacientams, sergantiems celiakijos liga per 6 savaičių trukmės vartojimo etapą.

Ongoing
2
160
Europe
ZED1227 10 mg capsules, ZED1227 50 mg capsules, ZED1227 100 mg capsules, Capsule, hard
Dr. Falk Pharma GmbH, Dr. Falk Pharma GmbH
Treatment of celiac disease, Inflammation in the small intestine, Diseases [C] - Digestive System Diseases [C06]
 
 
2020-004612-97: A clinical trial to evaluate ZED1227 in comparison with placebo in subjects with celiac disease experiencing symptoms despite gluten-free diet Kliininen tutkimus, jossa verrataan ZED1227-kapseleita lumelääkkeeseen keliakiaa sairastavilla tutkittavilla, joilla ilmenee oireita gluteenittomasta ruokavaliosta huolimatta

Ongoing
2
400
Europe, RoW
ZED1227, ZED1227 10 mg capsules, ZED1227 25 mg capsules, ZED1227 50 mg capsules, Capsule, hard
Dr. Falk Pharma GmbH, DR. FALK PHARMA GMBH, Dr. Falk Pharma GmbH
Treatment of celiac disease, Inflammation in the small intestine, Diseases [C] - Digestive System Diseases [C06]
 
 
NormaliZED, NCT05305599 / 2021-002253-29: Different Doses of ZED1227 vs. Placebo in NAFLD

Completed
2
186
Europe
ZED1227, Placebo
Dr. Falk Pharma GmbH, Dr. Falk Pharma GmbH
NAFLD, Liver Fibrosis
06/23
07/23
2021-002253-29: Different doses of ZED1227 vs. placebo in NAFLD Diferentes dosis de ZED1227 frente a placebo en NAFLD

Not yet recruiting
2
160
Europe
ZED1227, Capsule, hard
Dr. Falk Pharma GmbH, Dr. Falk Pharma GmbH
Non-alcoholic fatty liver disease with significant fibrosis Enfermedad del hígado graso no alcohólico con fibrosis significativa, Diseases [C] - Nutritional and Metabolic Diseases [C18]
 
 
NCT05818956: A Study of TAK-227 in Healthy Adults

Completed
1
24
US
TAK-227
Takeda
Healthy Volunteers
06/23
06/23
PR600 / Dr Falk, Merck (MSD)
MK-8690-001, NCT05603182: A Study of PRA052 in Healthy Volunteers

Completed
1
96
US
PRA052, Placebo
Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Healthy
02/24
02/24
Trial + Data / EventsStatusPhNRegionInterventionsSponsorConditionsPrimary complStudy compl
RhuDex (AV 1142742) / Dr Falk, Medigene
2020-001961-34: Clinical trial comparing the efficacy and safety of Rhudex granules with placebo in the treatment of the liver disease Primary Biliary Cholangitis

Ongoing
2
136
Europe
RhuDex 25 mg (31.75 mg RhuDex choline salt) granules, RhuDex 50 mg (63.5 mg RhuDex choline salt) granules, RhuDex 100 mg (127 mg RhuDex choline salt) granules, Granules
Dr. Falk Pharma GmbH, Dr. Falk Pharma GmbH
Primary biliary cholangitis, A type of long-term liver disease in which the bile ducts in the liver become damaged., Diseases [C] - Immune System Diseases [C20]
 
 
budesonide rectal foam / Generic mfg.
2009-015077-12: The use of corticosteroids (Budenofalk) as a chemopreventative agent in ulcerative colitis associated neoplasia

Ongoing
4
50
Europe
Budenofalk rectal foam, Budenofalk 2mg rectal foam, Budenofalk 2mg rectal foam
University Hospital Birmingham NHS Foundation Trust
chronic ulcerative colitis
 
 
NCT05976802: Dose Ranging Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Budesonide Rectal Foam in Pediatric Patients Aged 5 to 17 Years With Active, Mild to Moderate Distal Ulcerative Colitis

Not yet recruiting
4
100
NA
High dose budesonide rectal foam, Low dose budesonide rectal foam, Matching placebo rectal foam
Bausch Health Americas, Inc.
Ulcerative Colitis
06/25
06/25
2016-001921-15: Novel budesonide suppository vs. budesonide foam in acute ulcerative proctitis.

Ongoing
3
576
Europe
Budenofalk® suppositories (BUS), Budenofalk® 2 mg foam, Suppository, Rectal foam, Budenofalk® 2 mg foam
Dr. Falk Pharma GmbH, Dr. Falk Pharma GmbH
Acute Ulcerative Proctitis, Acute Ulcerative Proctitis - Inflammation of the Rectum, Diseases [C] - Digestive System Diseases [C06]
 
 
Budenofalk (budesonide gastro-resistant) / Dr Falk
2019-003334-16: Novel budenosid suppository in addition to basic therapy with oral mesalazine compared to basic therapy alone for treatment of ulcerative colitis

Not yet recruiting
3
360
Europe, RoW
Budenofalk® suppositories, Salofalk 3g gastro-resistant prolonged-release granules, Suppository, Gastro-resistant granules, Salofalk 3g gastro-resistant prolonged-release granules
Dr. Falk Pharma GmbH, Dr. Falk Pharma GmbH
acute ulcerative colitis, acute ulcerative colitis - inflammation and ulcers of the colon and rectum, Diseases [C] - Digestive System Diseases [C06]
 
 
NCT04921033: Exclusive Enteral Nutrition in Patients With Ileocaecal Crohn's Disease

Recruiting
3
256
RoW
EEN (Nestle Modulen®), Standart of care, Budesonide (Budenofalk®), Prednisolone (Deltacortril®), Azathioprine (Imuran®)
Duzce University
Crohn Disease, Nutrient; Excess, Remission/Regression
01/26
01/26
2019-003271-19: The influence of the body on the fate of budesonide in healthy volunteers de lichamelijke invloed op de vrijzetting van budesonide in gezonde vrijwilligers

Not yet recruiting
2
10
Europe
Budesonide Ferring, Budenofalk, Entocort, Nexiam, Tablet, Capsule, Capsule, hard
KU Leuven, KU Leuven
Healthy volunteers gezonde vrijwilligers, Healthy volunteers gezonde vrijwilligers, Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]
 
 
NCT06922305: Relative Bioavailability Study of HR19042 in Healthy Subjects

Completed
1
18
RoW
HR19042 Capsule, Tarpeyo®, Budenofalk®
Jiangsu HengRui Medicine Co., Ltd.
Primary IgA Nephropathy; Autoimmune Hepatitis
01/24
01/24
Salofalk suppository (mesalazine rectal suppository) / Dr Falk
ChiCTR2000028869: phase IIa clinical trial of Colitis Suppositories

Recruiting
2
60
 
Colitis Suppositories, one at a time, twice a day, in the early and late anal plug into the rectum. ;Mesalazine Suppositories, one at a time, twice a day, in the early and late anal plug into the rectum.
Beijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University; Shandong Kangzhonghong Medical Technology Development Co. Ltd., Self-financing and national project funding
mild-to-moderate active ulcerative colitis (Qi-Deficiency and Blood-Stasis Syndrome)
 
 
Budenofalk granules (budesonide gastro-resistant granules) / Dr Falk
ChiCTR2000039057: Clinical study of Wenshen Yiqi Granules in improving airway hypersecretion in patients with chronic obstructive pulmonary disease

Recruiting
4
60
 
Wenshen Yiqi Granules+ Tiotropium Bromide Powder Inhalation ;Tiotropium Bromide Powder Inhalation ;Wenshen Yiqi Granules+ Tiotropium Bromide Powder Inhalation+Budesonide formoterol inhalation powder ;Tiotropium Bromide Powder Inhalation+Budesonide formoterol inhalation powder
The Second Affiliated Hospital of Zhejiang Chinese Medical University; The Second Affiliated Hospital of Zhejiang Chinese Medical University, Zhejiang Administration of traditional Chinese Medicine
COPD
 
 
ChiCTR2000032826: Effect of Yinqiao Qingyan Granules in treating the acute bronchitis infected by respiratory syncytial virus in children

Not yet recruiting
N/A
120
 
Ribavirin granule was given orally and budesonide-solution was inhaled ;Yinqiao Qingyan granule was given orally
Guangdong Secondary Hospital of Traditional Chinese Medicine; Guangdong Secondary Hospital of Traditional Chinese Medicine, Scientific research project of guangdong administration of traditional Chinese medicine
Acute bronchitis infected by respiratory syncytial virus
 
 
ChiCTR2200061471: Randomized multicenter clinical evaluation of Xiaoer Dingchuan Granule in the intervention of respiratory syncytial virus pneumonia in children (phlegm-heat blocking lung syndrome)

Not yet recruiting
N/A
240
 
Xiaoer Dingchuan Granule combined with glucocorticoid budesonide suspension ;Glucocorticoid budesonide suspension
The Affiliated Hospital of Liaoning University of Traditional Chinese Medicine; The Affiliated Hospital of Liaoning University of Traditional Chinese Medicine, Pediatric Pneumonia Inheritance and Innovation Platform Construction Project (2020-1)
Respiratory syncytial virus pneumonia in children
 
 
ChiCTR2400083789: Clinical and mechanism study of Zhijing decoction on inhibiting airway remodeling of chronic persistent severe asthma by inhibiting ferroptosis

Not yet recruiting
N/A
60
 
budesonide/formoterol powder inhalation 320μg/9μg, batch number: H20140458 (AstraZeneca AB), one inhalation three times daily.; budesonide/formoterol powder inhalation 320μg/9μg, batch number: H20140458 (AstraZeneca AB), one inhalation three times daily.zhijing decoction(Centipede 3g, Scorpion 3g, Sichuan New Green Pharmaceutical Technology Development Co., LTD. Formula granules)
Shanghai Municipal Hospital of Traditional Chinese Medicine; Shanghai Municipal Hospital of Traditional Chinese Medicine, self-financing
asthma
 
 
Salofalk (mesalazine) / Dr Falk
2019-001009-26: Gastrointestinal behaviour of mesalazine in healthy volunteers Gastrointestinaal gedrag van mesalazine in gezonde vrijwilligers

Not yet recruiting
4
10
Europe
Modified-release tablet, Gastro-resistant tablet, Pentasa 500 mg tabletten met verlengde afgifte, Claversal 500 mg maagsapresistente tabletten, Mezavant 1.2 g maagsapresistente tabletten met verlengde afgifte, Nexiam, 40 mg Maagsap-resistente tabletten
KU Leuven - Drug Delivery and Disposition, KU Leuven
Healthy volunteers Gezonde vrijwilligers, Healthy volunteers Gezonde vrijwilligers, Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]
 
 
2022-001683-10: Describe the level of remission (illness is no longer active, is under control) in patients with ulcerative colitis who are treated with 5-ASA medication Beschrijven van de mate van remissie (ziekte is niet langer actief, is onder controle) bij patiënten met ulceratieve colitis, die behandeld worden met 5-ASA medicatie. Décrire le degré de rémission (la maladie n'est plus active, elle est sous contrôle) chez les patients atteints de colite ulcéreuse traités par des médicaments 5-ASA.

Not yet recruiting
4
200
Europe
Gastro-resistant tablet, Suppository, Rectal foam, Gastro-resistant granules for oral suspension in sachet, Tablet, Granules for oral solution in sachet, Rectal suspension, Claversal, Colitofalk, Pentasa, Mezavant, Mesalazine Teva, Salazopyrine
BIRD vzw (Belgian IBD Research and Development), BIRD vzw, Ferring N.V.
Ulcerative colitis Ulceratieve colitis Colite Ulcéreuse, Chronic inflammation of the large bowel Chronische ontsteking van de dikke darm Inflammation chronique du côlon, Diseases [C] - Digestive System Diseases [C06]
 
 
Salofalk prolonged-release granules (mesalazine gastro-resistant prolonged-release granules) / Dr Falk
2006-006198-26: Mechanistic randomised contorlled trial of Mesalazine in symptomatic diverticular disease

Ongoing
4
40
Europe
Mesalazine, Salofalk 1000mg granules, Salofalk 1000mg granules
University of Nottingham
Symptomatic diverticular disease defines as patients with recurrent abdominal pain on more then 3 days per month with proven diverticula.
 
 
Aemcolo (rifamycin SV MMX) / Cosmo Pharma, RedHill, Dr Falk
NCT04501380: Efficacy of AEMCOLO (Rifamycin SV MMX) in the Treatment of Small Intestinal Bacterial Overgrowth (SIBO)

Enrolling by invitation
2
30
US
AEMCOLO (Rifamycin SV MMX)
Bradley Connor
Small Intestinal Bacterial Overgrowth, Gastrointestinal Disease, Gastrointestinal Infection
12/22
12/22
RIVET, NCT04082780: Rifamycin in Minimal Hepatic Encephalopathy

Completed
2
30
US
Rifamycin SV MMX, Aemcolo, Placebo
Hunter Holmes Mcguire Veteran Affairs Medical Center
Hepatic Encephalopathy, Cirrhosis, Liver
04/23
04/23
NCT04027894: Study to Evaluate Safety and Efficacy of Rifamycin SV MMX in Treating Traveler's Diarrhea in Children Age 12 to 17 Years

Not yet recruiting
2
142
NA
Rifamycin SV MMX, Rifamycin, Placebo to Rifamycin SV-MMX, Placebo
RedHill Biopharma Limited
Traveler's Diarrhea
01/25
12/25
NCT04026984: Evaluate Safety and Efficacy of Rifamycin SV MMX in the Treatment of Traveler's Diarrhea in Children Age 6 to 11 Years

Not yet recruiting
2
142
NA
Rifamycin SV-MMX, Rifamycin, Placebo
RedHill Biopharma Limited
Traveler's Diarrhea
06/25
12/25
Jorveza (budesonide orodispersible tablets) / Dr Falk
2020-002593-27: Budesonide as a treatment for inflammation in stomach complaints. Budesonide als behandeling voor ontstekingsreacties bij maagklachten.

Not yet recruiting
4
36
Europe
Budesonide, Capsule, Jorveza
UZ Leuven, KU Leuven
Functional dyspepsia Functionele dyspepsie, Chronic stomach disease Chronische maagklachten, Diseases [C] - Digestive System Diseases [C06]
 
 
2020-001314-37: clinical study to show equal clinical efficacy of two dosing regimen of budesonid orodispersible tablets (twice daily vs. once daily) for treatment of inflammation of the esophagus

Not yet recruiting
3
242
Europe
Budesonide 2 mg orodispersible tablets (BUL 2 mg), Budesonide 1 mg orodispersible tablets (BUL 1 mg), Orodispersible tablet, Jorveza
Dr. Falk Pharma GmbH, Dr. Falk Pharma GmbH
eosinophilic esophagitis Eosinophile Ösophagitis, allergy-like, chronic inflammation of the esophagus allergieartige, chronische Entzündung der Speiseröhre, Diseases [C] - Digestive System Diseases [C06]
 
 
2017-003516-39: A phase III clinical study in adult and adolescent patients with eosinophilic inflammation of the gullet to prove superiority compared to placebo of an episodic and/or a continuous 48-week treatment with budesonide orodispersible tablets for maintaining remission Klinische Studie der Phase III mit erwachsenen und jugendlichen Patienten mit eosinophiler Entzündung der Speiseröhre zum Nachweis der Überlegenheit einer 48-wöchigen Behandlung in Episoden und/oder fortlaufend mit Budesonid Schmelztabletten im Vergleich zu Plazebo zur Aufrechterhaltung einer Remission.

Ongoing
3
110
Europe
Budesonide 1 mg orodispersible tablets, Budesonide 0.5 mg orodispersible tablets, BUL 1 mg, BUL 0.5 mg, Orodispersible tablet, Jorveza 1 mg orodispersible tablets, Jorveza 0.5 mg orodispersible tablets
Dr. Falk Pharma GmbH, DR. FALK PHARMA GMBH, Dr. Falk Pharma GmbH, DR. FALK PHARMA GmbH
Maintenance of remission in eosinophilic esophagitis Remissionserhalt der eosinophilen Ösophagitis, Chronic allergic/immune-mediated inflammatory disease of the gullet in its remission phase Chronisch allergische/immun-vermittelte entzündliche Erkrankung der Speiseröhre in ihrer Remissionsphase, Diseases [C] - Digestive System Diseases [C06]
 
 
EOS-4, NCT06596252 / 2020-001314-37: Once Daily Versus Twice Daily Budesonide Orodispersible Tablets for Induction of Remission in EoE

Recruiting
3
308
Europe, US
Budesonide
Dr. Falk Pharma GmbH, Dr. Falk Pharma GmbH
Eosinophilic Esophagitis
08/25
09/25
2018-002617-35: Double-blinded (treatment group unknown to physician and patient), randomised (treatment group allocated by chance) phase II trial on the efficacy and tolerability of an 8 week treatment with two different doses of budesonide tablets dissolving in the mouth compared to placebo (medication without active substance), for prevention of constrictions of the oesophagus in adult patients after removal of cancer tissue using an endoscopic surgery technique Doppelt verblindete (weder Arzt noch Patient kennen die Behandlungsgruppe), randomisierte (Behandlungsgruppe per Zufallsprinzip) Phase II Studie zur Wirksamkeit und Verträglichkeit einer 8-wöchigen Behandlung zweier Dosierungen einer sich im Mund auflösenden Budesonid-Tablette im Vergleich zu Plazebo (Scheinmedikament), zur Verhinderung von Verengungen der Speiseröhre bei erwachsenen Patienten nach Entfernung von Speiseröhrenkrebsgewebe mit Hilfe einer endoskopischen Operationstechnik

Not yet recruiting
2
90
Europe
2 mg budesonide orodispersible tablet, BUL 2 mg, Orodispersible tablet, Jorveza 1 mg orodispersible tablets
Dr. Falk Pharma GmbH, Dr. Falk Pharma GmbH
Prevention of oesophageal strictures in adult patients after endoscopic submucosal dissection Verhinderung von Strikturen der Speiseröhre bei erwachsenen Patienten nach endoskopischer Submukosadissektion, Prevention of strictures of the oesophagus in adult patients after removal of cancer tissue from the oesophagus using an endoscopic surgery technique Verhinderung von Verengungen der Speiseröhre bei erwachsenen Patienten, bei denen Gewebe eines Speiseröhrenkrebs mit Hilfe einer endoskopischen Operationstechnik entfernt wurde, Diseases [C] - Digestive System Diseases [C06]
 
 
Switch, NCT05594849: Evaluation of Efficacy, Safety and Patient' Satisfaction of Therapeutic From Off-Steroids to Budesonide

Completed
N/A
31
Europe
Budesonide Orodispersible Tablets (Jorveza)
Istituto Clinico Humanitas
Eosinophilic Esophagitis
10/23
10/23
norucholic acid (norUDCA) / Dr Falk
2016-003367-19: A study to compare norursodeoxycholic acid with placebo in the treatment of primary sclerosing cholangitis

Ongoing
3
300
Europe, RoW
Norursodeoxycholic acid, [NorUDCA], Capsule
Dr. Falk Pharma GmbH, DR. FALK PHARMA GMBH, Dr. Falk Pharma GmbH,
Primary Sclerosing Cholangitis (PSC) is a slowly progressing chronic cholestatic liver disease of assumed autoimmune, but finally unidentified etiology, characterized by a chronic inflammatory and fibro-obliterative destruction of extra-, and intrahepatic bile ducts. The disease is characterized by diffuse inflammation, fibrosis, and strictures of the intra- and/or extrahepatic bile ducts with an impaired biliary secretion of potentially aggressive bile fluid often leading to cirrhosis., Primary Sclerosing Cholangitis (PSC) is a slowly progressing chronic liver disease characterized by changes in the gall ducts inside and/or outside the liver, such as narrowing or enlargement., Diseases [C] - Digestive System Diseases [C06]
 
 
NCT03872921: norUrsodeoxycholic Acid vs Placebo in PSC

Active, not recruiting
3
303
Europe
norUrsodeoxycholic Acid, NUC
Dr. Falk Pharma GmbH
Primary Sclerosing Cholangitis
01/25
06/26
NCT06886360: Study with Norucholic Acid Tablets in Patients with Primary Sclerosing Cholangitis (PSC)

Not yet recruiting
3
120
NA
norucholic acid
Dr. Falk Pharma GmbH
Primary Sclerosing Cholangitis
09/27
09/27
2013-004605-38: Clinical trial comparing different doses of norursodeoxycholic acid capsules with placebo in the treatment of non-alcoholic fatty liver disease Klinische Studie welche zwei verschiedene Konzentrationen von Norursodeoxycholsäure Kapseln mit Placebo in der Behandlung der nicht alkoholischen Fettleber vergleicht

Ongoing
2
156
Europe
Norursodeoxycholic acid, norUDCA,
Dr. Falk Pharma GmbH, Dr. Falk Pharma GmbH
Non-alcoholic fatty liver disease (NAFLD)
 
 
2021-001431-56: Clinical study comparing two doses of norucholic acid against placebo in the treatment of a liver disease called primary biliary cholangitis in patients without sufficient response to ursodeoxycholic acid

Ongoing
2
90
Europe
Norucholic acid (NCA) 500 mg, NCA 500mg, Film-coated tablet
Dr. Falk Pharma GmbH, Dr. Falk Pharma GmbH
primary biliary cholangitis, Primary biliary cholangitis is a rare chronic liver disease, Diseases [C] - Digestive System Diseases [C06]
 
 
NCT05083390 / 2018-003443-31: Norursodeoxycholic Acid vs. Placebo in NASH

Recruiting
2
363
Europe
norUrsodeoxycholic acid, norucholic acid, norUDCA, NCA
Dr. Falk Pharma GmbH, Dr. Falk Pharma GmbH,
Nonalcoholic Steatohepatitis
01/25
04/25
TAK-227 / Takeda
2017-002241-30: Clinical trial with ZED1227 capsules compared to placebo in subjects with celiac disease during a 6-week treatment. Klinikinis tyrimas su tiriamuoju vaistiniu preparatu (TVP) ZED1227 kapsulės, lyginant jį su placebu (jo sudėtyje nėra veikliosios medžiagos), pacientams, sergantiems celiakijos liga per 6 savaičių trukmės vartojimo etapą.

Ongoing
2
160
Europe
ZED1227 10 mg capsules, ZED1227 50 mg capsules, ZED1227 100 mg capsules, Capsule, hard
Dr. Falk Pharma GmbH, Dr. Falk Pharma GmbH
Treatment of celiac disease, Inflammation in the small intestine, Diseases [C] - Digestive System Diseases [C06]
 
 
2020-004612-97: A clinical trial to evaluate ZED1227 in comparison with placebo in subjects with celiac disease experiencing symptoms despite gluten-free diet Kliininen tutkimus, jossa verrataan ZED1227-kapseleita lumelääkkeeseen keliakiaa sairastavilla tutkittavilla, joilla ilmenee oireita gluteenittomasta ruokavaliosta huolimatta

Ongoing
2
400
Europe, RoW
ZED1227, ZED1227 10 mg capsules, ZED1227 25 mg capsules, ZED1227 50 mg capsules, Capsule, hard
Dr. Falk Pharma GmbH, DR. FALK PHARMA GMBH, Dr. Falk Pharma GmbH
Treatment of celiac disease, Inflammation in the small intestine, Diseases [C] - Digestive System Diseases [C06]
 
 
NormaliZED, NCT05305599 / 2021-002253-29: Different Doses of ZED1227 vs. Placebo in NAFLD

Completed
2
186
Europe
ZED1227, Placebo
Dr. Falk Pharma GmbH, Dr. Falk Pharma GmbH
NAFLD, Liver Fibrosis
06/23
07/23
2021-002253-29: Different doses of ZED1227 vs. placebo in NAFLD Diferentes dosis de ZED1227 frente a placebo en NAFLD

Not yet recruiting
2
160
Europe
ZED1227, Capsule, hard
Dr. Falk Pharma GmbH, Dr. Falk Pharma GmbH
Non-alcoholic fatty liver disease with significant fibrosis Enfermedad del hígado graso no alcohólico con fibrosis significativa, Diseases [C] - Nutritional and Metabolic Diseases [C18]
 
 
NCT05818956: A Study of TAK-227 in Healthy Adults

Completed
1
24
US
TAK-227
Takeda
Healthy Volunteers
06/23
06/23
PR600 / Dr Falk, Merck (MSD)
MK-8690-001, NCT05603182: A Study of PRA052 in Healthy Volunteers

Completed
1
96
US
PRA052, Placebo
Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Healthy
02/24
02/24

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