Signs and Symptoms, Digestive News - LARVOL Sigma

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88 Mechanisms of Action

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||||||||||  Dificid (fidaxomicin) / Merck (MSD), Astellas
New P2a trial:  Safety, Tolerability, and Pharmacokinetics of Fidaxomicin in Pediatric Subjects With Clostridium Difficile-associated Diarrhea (CDAD) (clinicaltrials.gov) -  May 2, 2012
P2a, N=32, Completed,  Sponsor: Optimer Pharmaceuticals

|||||||||| Enrollment open: Hormonal Therapy for Teens With Anorexia Nervosa (clinicaltrials.gov) - May 2, 2012
P3, N=70, Recruiting, Sponsor: Children's Hospital Boston
Not yet recruiting --> Recruiting

|||||||||| Trial completion: Use of Pyridostigmine for Constipation in Diabetics (clinicaltrials.gov) - May 1, 2012
P1/2, N=30, Completed, Sponsor: Mayo Clinic
Not yet recruiting --> Recruiting Active, not recruiting --> Completed

||||||||||  Apokyn (apomorphine bolus injection) / Stada, Supernus Pharma, Aguettant
Enrollment change:  Safety/Efficacy of Tigan® to Control Nausea/Vomiting Experienced During Apokyn® Initiation and Treatment (clinicaltrials.gov) -  Apr 29, 2012
P4, N=117, Completed,  Sponsor: Ipsen
Active, not recruiting --> Completed N=180 --> 117

||||||||||  Apokyn (apomorphine bolus injection) / Stada, Supernus Pharma, Aguettant
Trial completion:  Safety/Efficacy of Tigan® to Control Nausea/Vomiting Experienced During Apokyn® Initiation and Treatment (clinicaltrials.gov) -  Apr 29, 2012
P4, N=117, Completed,  Sponsor: Ipsen
N=180 --> 117 Recruiting --> Completed

||||||||||  omeprazole / Generic mfg.
New P4 trial:  Comparison of Two Omeprazole-Containing Products for Relief of Frequent Heartburn (MK-0764A-036) (clinicaltrials.gov) -  Apr 26, 2012
P4, N=48, Completed,  Sponsor: Merck Sharp & Dohme Corp.

||||||||||  Zelnorm (tegaserod) / Novartis
Enrollment change:  Safety and Efficacy of Tegaserod in Opioid-induced Constipation in Patients With Non-cancer Pain. (clinicaltrials.gov) -  Apr 18, 2012
P3, N=11, Terminated,  Sponsor: Novartis
Recruiting --> Completed N=400 --> 11

|||||||||| Clinical: Reletex for Nausea in GERD Patients (clinicaltrials.gov) - Apr 18, 2012
P=N/A, N=30, Recruiting, Sponsor: Northwestern University

|||||||||| Enrollment change, MRI: Appetite-Related Brain Activity in Women With Anorexia Nervosa (clinicaltrials.gov) - Apr 17, 2012
P=N/A, N=15, Completed, Sponsor: New York State Psychiatric Institute
N=400 --> 11 N=20 --> 15

|||||||||| Trial withdrawal: Assessment of Gastric Emptying Speed in Patients Who Experience Diarrhea Following a Trigger Meal (clinicaltrials.gov) - Apr 17, 2012
P=N/A, N=0, Withdrawn, Sponsor: Money, Mary E., M.D.
N=20 --> 15 Recruiting --> Withdrawn

|||||||||| Enrollment change: Assessment of Gastric Emptying Speed in Patients Who Experience Diarrhea Following a Trigger Meal (clinicaltrials.gov) - Apr 17, 2012
P=N/A, N=0, Withdrawn, Sponsor: Money, Mary E., M.D.
Recruiting --> Withdrawn N=20 --> 0

|||||||||| Enrollment change: Impact of Preventive and Therapeutic Zinc Supplementation Programs Among Young Children (clinicaltrials.gov) - Apr 16, 2012
P4, N=7680, Completed, Sponsor: University of California, Davis
N=20 --> 0 N=6300 --> 7680

|||||||||| Trial completion: Impact of Preventive and Therapeutic Zinc Supplementation Programs Among Young Children (clinicaltrials.gov) - Apr 16, 2012
P4, N=7680, Completed, Sponsor: University of California, Davis
N=6300 --> 7680 Recruiting --> Completed

||||||||||  Amitiza (lubiprostone) / Takeda, Mallinckrodt
Enrollment change:  Lubiprostone as a Treatment for Constipation in Parkinson's Disease (clinicaltrials.gov) -  Apr 15, 2012
P=N/A, N=1, Terminated,  Sponsor: University of Arkansas
Recruiting --> Completed N=40 --> 1

||||||||||  acetylcysteine solution / Generic mfg.
Trial termination:  N-acetylcysteine in the Treatment of Bulimia Nervosa (clinicaltrials.gov) -  Apr 10, 2012
P3, N=11, Terminated,  Sponsor: Lindner Center of HOPE
N=40 --> 1 Recruiting --> Terminated

||||||||||  acetylcysteine solution / Generic mfg.
Enrollment change:  N-acetylcysteine in the Treatment of Bulimia Nervosa (clinicaltrials.gov) -  Apr 10, 2012
P3, N=11, Terminated,  Sponsor: Lindner Center of HOPE
Recruiting --> Terminated N=15 --> 11

||||||||||  Tiorfan (racecadotril) / Bioprojet
New P4 trial:  Efficacy of Racecadotril in Acute Watery Diarrhea in Children (clinicaltrials.gov) -  Apr 10, 2012
P4, N=52, Completed,  Sponsor: Centro Pediatrico Albina de Patino

|||||||||| New P3 trial, Surgery: Effect of Intravenous Fluid Therapy on Postoperative Vomiting in Children Undergoing Otorhinolaryngological Surgery (clinicaltrials.gov) - Apr 9, 2012
P3, N=100, Completed, Sponsor: Ignacio Cortínez F.

|||||||||| Trial completion: Effectiveness of Cognitive Remediation Therapy in Improving Treatment Retention in People With Anorexia Nervosa (clinicaltrials.gov) - Apr 8, 2012
P1, N=46, Completed, Sponsor: Stanford University
N=15 --> 11 Active, not recruiting --> Completed

|||||||||| Trial completion: Effectiveness of Family-Based Versus Individual Psychotherapy in Treating Adolescents With Anorexia Nervosa (clinicaltrials.gov) - Apr 8, 2012
P1, N=120, Completed, Sponsor: Stanford University
Active, not recruiting --> Completed Active, not recruiting --> Completed

|||||||||| New P4 trial: Efficacy of Use of Zinc in the Treatment of Acute Diarrhea in Infants (clinicaltrials.gov) - Apr 3, 2012
P4, N=52, Completed, Sponsor: Centro Pediatrico Albina de Patino

|||||||||| New P2 trial: Proof-of-Concept, Calcium Aluminosilicate Anti-Diarrheal (CASAD) for Treatment of Clostridium Difficile Infection (clinicaltrials.gov) - Apr 2, 2012
P2, N=2, Terminated, Sponsor: Salient Pharmaceuticals Incorporated

|||||||||| Trial completion: Internet Intervention for Childhood Encopresis (clinicaltrials.gov) - Apr 1, 2012
P=N/A, N=290, Completed, Sponsor: University of Virginia
Active, not recruiting --> Completed Active, not recruiting --> Completed

||||||||||  palonosetron intravenous / Generic mfg.
New P3 trial:  Therapeutic Efficacy and Safety of Palonosetron in Treatment of Postoperative Nausea and Vomiting (clinicaltrials.gov) -  Mar 29, 2012
P3, N=384, Completed,  Sponsor: Samsung Medical Center

|||||||||| Trial completion: Safety and Immunogenicity of Single Dose Choleragarde® in HIV-Seropositive Adults (clinicaltrials.gov) - Mar 28, 2012
P2, N=32, Completed, Sponsor: International Vaccine Institute
Active, not recruiting --> Completed Recruiting --> Completed

|||||||||| Trial completion: Mass Oral Cholera Vaccination in Zanzibar (clinicaltrials.gov) - Mar 28, 2012
P=N/A, N=51151, Completed, Sponsor: International Vaccine Institute
Recruiting --> Completed Recruiting --> Completed

|||||||||| Enrollment open: Dose-Responsive Effect of Polydextrose on Whole Gut Transit Time (clinicaltrials.gov) - Mar 26, 2012
P=N/A, N=184, Recruiting, Sponsor: Danisco
Recruiting --> Completed Not yet recruiting --> Recruiting

|||||||||| Trial completion: Serotonin Transporter Concentrations in Women With a History of Anorexia Nervosa (clinicaltrials.gov) - Mar 25, 2012
P=N/A, N=20, Completed, Sponsor: New York State Psychiatric Institute
Not yet recruiting --> Recruiting Recruiting --> Completed

||||||||||  dronabinol oral / Generic mfg.
New P2 trial:  The Analgesic Efficacy of Δ9-THC (Namisol®) in Patients With Persistent Postsurgical Abdominal Pain (clinicaltrials.gov) -  Mar 21, 2012
P2, N=68, Recruiting,  Sponsor: Radboud University

||||||||||  pregabalin / Generic mfg.
Enrollment change:  Pregabalin for Abdominal Pain From Adhesions (clinicaltrials.gov) -  Mar 21, 2012
P4, N=18, Terminated,  Sponsor: Henry Ford Health System
Recruiting --> Completed N=100 --> 18

|||||||||| Trial completion: Effect of Diet on Intestinal Gas Production and Evacuation in Healthy Subjects and Flatulent Patients (clinicaltrials.gov) - Mar 21, 2012
P=N/A, N=50, Completed, Sponsor: Hospital Universitari Vall d'Hebron Research Institute
N=100 --> 18 Recruiting --> Completed

|||||||||| New P2 trial: A Safety, Tolerability and Pharmacokinetic Study of Two Formulations of Metronidazole Versus Immediate Release Metronidazole in Patient With C. Difficile Colitis (clinicaltrials.gov) - Mar 19, 2012
P2, N=60, Completed, Sponsor: Dr. Reddy's Laboratories Limited

|||||||||| New P3 trial: Diarrhea and Bivalent Oral Polio Vaccine Immunity (clinicaltrials.gov) - Mar 19, 2012
P3, N=0, Withdrawn, Sponsor: Centers for Disease Control and Prevention

|||||||||| New P3 trial: CLONEMESI: Transdermal Clonidine in the Treatment of Severe Hyperemesis Gravidarum (clinicaltrials.gov) - Mar 18, 2012
P3, N=13, Completed, Sponsor: Azienda Ospedaliera Città della Salute e della Scienza di Torino

||||||||||  ondansetron intravenous / Generic mfg., dexamethasone injection / Generic mfg., palonosetron intravenous / Generic mfg.
Trial initiation date:  Palonosetron, Ondansetron, and Dexamethasone for Delayed Nausea and Vomiting in Autologous Transplant Patients (clinicaltrials.gov) -  Mar 18, 2012
P2, N=85, Recruiting,  Sponsor: Northside Hospital, Inc.
Recruiting --> Completed Initiation date: Jul 2011 --> Feb 2012

||||||||||  ondansetron intravenous / Generic mfg., dexamethasone injection / Generic mfg., palonosetron intravenous / Generic mfg.
Enrollment open:  Palonosetron, Ondansetron, and Dexamethasone for Delayed Nausea and Vomiting in Autologous Transplant Patients (clinicaltrials.gov) -  Mar 18, 2012
P2, N=85, Recruiting,  Sponsor: Northside Hospital, Inc.
Initiation date: Jul 2011 --> Feb 2012 Not yet recruiting --> Recruiting

|||||||||| New P1/2 trial: Effects of Bolus and Continuous Nasogastric Feeding on Small Bowel Water Content and Blood Flow (clinicaltrials.gov) - Mar 15, 2012
P1/2, N=12, Completed, Sponsor: University of Nottingham

||||||||||  Varubi (rolapitant oral) / TerSera Therap, GSK
Enrollment open, CINV:  Ph3 Safety/Efficacy Study of Rolapitant for the Prevention of CINV in Subjects Receiving Highly Emetogenic Chemotherapy (clinicaltrials.gov) -  Mar 15, 2012
P3, N=530, Recruiting,  Sponsor: Tesaro, Inc.
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting

||||||||||  Linzess (linaclotide) / Astellas, Ironwood Pharma, AbbVie
Trial completion:  An Open-label, Long-term Safety Study of Linaclotide in Patients With Chronic Constipation or Irritable Bowel Syndrome With Constipation (clinicaltrials.gov) -  Mar 15, 2012
P3, N=1743, Completed,  Sponsor: Ironwood Pharmaceuticals, Inc.
Not yet recruiting --> Recruiting Active, not recruiting --> Completed

|||||||||| Trial completion: Traveler's Diarrhea (TD) Vaccine Asia Efficacy Study (clinicaltrials.gov) - Mar 12, 2012
P2, N=723, Completed, Sponsor: Intercell USA, Inc.
Active, not recruiting --> Completed Active, not recruiting --> Completed

|||||||||| Trial completion: Travelers' Diarrhea (TD) Vaccine Pivotal Efficacy Study (clinicaltrials.gov) - Mar 12, 2012
P3, N=2036, Completed, Sponsor: Intercell USA, Inc.
Active, not recruiting --> Completed Active, not recruiting --> Completed

||||||||||  Viberzi (eluxadoline) / AbbVie
New P3 trial:  Efficacy, Safety, and Tolerability of Eluxadoline in the Treatment of Participants With Diarrhea-Predominant Irritable Bowel Syndrome (IBS-d) (clinicaltrials.gov) -  Mar 12, 2012
P3, N=1150, Completed,  Sponsor: Furiex Pharmaceuticals, Inc

||||||||||  Viberzi (eluxadoline) / AbbVie
New P3 trial:  Efficacy, Safety, and Tolerability of Eluxadoline in the Treatment of Participants With Diarrhea-Predominant Irritable Bowel Syndrome (IBS-d) (clinicaltrials.gov) -  Mar 12, 2012
P3, N=1125, Active, not recruiting,  Sponsor: Furiex Pharmaceuticals, Inc

||||||||||  dronabinol oral / Generic mfg.
New P2 trial:  Δ9-THC (Namisol®) in Chronic Pancreatitis Patients Suffering From Persistent Abdominal Pain (clinicaltrials.gov) -  Mar 8, 2012
P2, N=68, Recruiting,  Sponsor: Radboud University

||||||||||  morphine sulphate / Generic mfg.
New P4 trial:  Buprenorphine in Acute Renal Colic Pain Management (clinicaltrials.gov) -  Mar 5, 2012
P4, N=80, Completed,  Sponsor: Tehran University of Medical Sciences

||||||||||  dexamethasone / Generic mfg., ondansetron intravenous / Generic mfg.
New P2 trial:  Prevention Post Operative Nausea Vomiting in Ambulatory Gynecologic Laparoscopy (clinicaltrials.gov) -  Mar 1, 2012
P2, N=340, Completed,  Sponsor: Prince of Songkla University

||||||||||  elsiglutide (ZP1846) / Zealand Pharma
New P2 trial:  Proof-of-Concept Study in Cancer Patients to Assess Efficacy of Elsiglutide in Preventing Chemotherapy-Induced Diarrhea (clinicaltrials.gov) -  Mar 1, 2012
P2, N=138, Completed,  Sponsor: Helsinn Healthcare SA

||||||||||  dexloxiglumide (CR2017) / Mylan
Enrollment change:  The Safety and Efficacy of Dexloxiglumide for the Relief of Symptoms of Functional Dyspepsia. (clinicaltrials.gov) -  Feb 29, 2012
P2, N=48, Completed,  Sponsor: Forest Laboratories
Active, not recruiting --> Completed N=200 --> 48

||||||||||  Xifaxan (rifaximin) / Alfa Wassermann, Bausch Health, Norgine, ASKA Pharma
New P3 trial:  TARGET3t: Irritable Bowel Syndrome With Diarrhea (IBS-D) Rifaximin Re-Treatment Study (clinicaltrials.gov) -  Feb 29, 2012
P3, N=800, Active, not recruiting,  Sponsor: Salix Pharmaceuticals

|||||||||| New P2 trial: Lactobacillus Reuteri DSM 17938 Versus Placebo in the Treatment of Infantile Colic (clinicaltrials.gov) - Feb 27, 2012
P2, N=100, Recruiting, Sponsor: The Hospital for Sick Children