Gastroparesis News - LARVOL Sigma

Gastroparesis

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13 Mechanisms of Action

||||||||||  tadalafil / Generic mfg.
Enrollment change:  Daily Tadalafil and Gastric Emptying Time in Diabetic Gastroparesis (clinicaltrials.gov) -  Dec 4, 2013
P4, N=1, Terminated,  Sponsor: Mark Feinglos
N=10 --> 1

|||||||||| Enrollment change: The Effect of Acupuncture on Symptoms, Gastric Emptying Rate and Glucose Control in Patients With Diabetic Gastroparesis (clinicaltrials.gov) - Dec 4, 2013
P=N/A, N=8, Terminated, Sponsor: Rabin Medical Center
N=10 --> 1 N=30 --> 8

||||||||||  velusetrag (TD-5108) / Innoviva
Enrollment closed, P2 data:  Phase 2 Study of Velusetrag in Diabetic or Idiopathic Gastroparesis (clinicaltrials.gov) -  Nov 7, 2013
P2, N=32, Active, not recruiting,  Sponsor: Theravance, Inc.
N=30 --> 8 Recruiting --> Active, not recruiting

||||||||||  Januvia (sitagliptin) / Merck (MSD)
Trial completion:  Effects of Sitagliptin on Gastric Emptying in Healthy Subjects (clinicaltrials.gov) -  Nov 4, 2013
P1, N=15, Completed,  Sponsor: Royal Adelaide Hospital
Recruiting --> Active, not recruiting Active, not recruiting --> Completed

|||||||||| Enrollment closed, HEOR: Medico-economic Evaluation of ENTERRA Therapy (clinicaltrials.gov) - Oct 14, 2013
P=N/A, N=220, Active, not recruiting, Sponsor: University Hospital, Rouen
Active, not recruiting --> Completed Recruiting --> Active, not recruiting

|||||||||| Enrollment change: Domperidone for Gastroparesis in Solid Organ Transplantation (clinicaltrials.gov) - Oct 13, 2013
P=N/A, N=5, Terminated, Sponsor: David J. Lederer, M.D.
Recruiting --> Active, not recruiting N=25 --> 5

||||||||||  relamorelin (RM-131) / AbbVie
Enrollment change:  Phase 2 Study to Evaluate Safety & Efficacy of RM-131 Administered to Patients With Diabetic Gastroparesis (clinicaltrials.gov) -  Oct 9, 2013
P2, N=185, Active, not recruiting,  Sponsor: Rhythm Pharmaceuticals, Inc.
N=25 --> 5 N=125 --> 185

||||||||||  relamorelin (RM-131) / AbbVie
Enrollment closed:  Phase 2 Study to Evaluate Safety & Efficacy of RM-131 Administered to Patients With Diabetic Gastroparesis (clinicaltrials.gov) -  Oct 9, 2013
P2, N=185, Active, not recruiting,  Sponsor: Rhythm Pharmaceuticals, Inc.
N=125 --> 185 Recruiting --> Active, not recruiting

|||||||||| Enrollment open: Self-Propelled Versus Standard Percutaneous Endoscopic Gastrojejunostomy(PEG-J); RCT (clinicaltrials.gov) - Sep 24, 2013
P2, N=60, Recruiting, Sponsor: Johns Hopkins University
Recruiting --> Active, not recruiting Active, not recruiting --> Recruiting

||||||||||  camicinal (GSK962040) / GSK
New P2 trial:  Nutritional Adequacy Therapeutic Enhancement in the Critically Ill. The NUTRIATE Study (clinicaltrials.gov) -  Sep 2, 2013
P2, N=150, Recruiting,  Sponsor: GlaxoSmithKline

||||||||||  azithromycin / Generic mfg.
Trial termination:  Comparison of Two Macrolides, Azithromycin and Erythromycin, for Symptomatic Treatment of Gastroparesis (clinicaltrials.gov) -  Jul 15, 2013
P2, N=37, Terminated,  Sponsor: University of Florida
Active, not recruiting --> Recruiting Active, not recruiting --> Terminated; Original investigator left this institution, replacement investigator retired.

||||||||||  azithromycin / Generic mfg.
Enrollment change:  Comparison of Two Macrolides, Azithromycin and Erythromycin, for Symptomatic Treatment of Gastroparesis (clinicaltrials.gov) -  Jul 15, 2013
P2, N=37, Terminated,  Sponsor: University of Florida
Active, not recruiting --> Terminated; Original investigator left this institution, replacement investigator retired. N=50 --> 37

|||||||||| New P2 trial: Self-Propelled Versus Standard Percutaneous Endoscopic Gastrojejunostomy(PEG-J); RCT (clinicaltrials.gov) - Jul 2, 2013
P2, N=60, Recruiting, Sponsor: Johns Hopkins University

|||||||||| Trial initiation date: Phase 2 Study to Evaluate the Preliminary Performance of the C13-URA Breath Test Kit in Dyspeptic Subjects (clinicaltrials.gov) - Jul 1, 2013
P2, N=36, Recruiting, Sponsor: Otsuka Pharmaceutical Co., Ltd.
N=50 --> 37 Initiation date: Aug 2012 --> Jul 2013

|||||||||| Enrollment open: Phase 2 Study to Evaluate the Preliminary Performance of the C13-URA Breath Test Kit in Dyspeptic Subjects (clinicaltrials.gov) - Jul 1, 2013
P2, N=36, Recruiting, Sponsor: Otsuka Pharmaceutical Co., Ltd.
Initiation date: Aug 2012 --> Jul 2013 Not yet recruiting --> Recruiting

||||||||||  Gimoti (metoclopramide intranasal) / Evoke Pharma
Enrollment change:  Efficacy and Safety of Metoclopramide Nasal Spray Solution in Diabetic Patients With Gastroparesis (clinicaltrials.gov) -  May 27, 2013
P2, N=287, Completed,  Sponsor: Evoke Pharma
Not yet recruiting --> Recruiting N=225 --> 287

||||||||||  Gimoti (metoclopramide intranasal) / Evoke Pharma
Trial completion:  Efficacy and Safety of Metoclopramide Nasal Spray Solution in Diabetic Patients With Gastroparesis (clinicaltrials.gov) -  May 27, 2013
P2, N=287, Completed,  Sponsor: Evoke Pharma
N=225 --> 287 Active, not recruiting --> Completed

|||||||||| Trial termination, HEOR: Needs Assessment Evaluating Quality of Life Issues for Gastroparesis Patients and Caregivers (clinicaltrials.gov) - May 16, 2013
P=N/A, N=68, Terminated, Sponsor: University of Florida
Active, not recruiting --> Completed Recruiting --> Terminated; PI left institution,replacement PI not able to do study.

|||||||||| Enrollment change, HEOR: Needs Assessment Evaluating Quality of Life Issues for Gastroparesis Patients and Caregivers (clinicaltrials.gov) - May 16, 2013
P=N/A, N=68, Terminated, Sponsor: University of Florida
Recruiting --> Terminated; PI left institution,replacement PI not able to do study. N=200 --> 68

|||||||||| Clinical: Clinical Applications of Domperidone in Patients With Delayed Gastric Emptying (clinicaltrials.gov) - Apr 29, 2013
P=N/A, N=500, Recruiting, Sponsor: Mt. Sinai Medical Center, Miami

|||||||||| Trial completion: Affects of Once-daily Oral Administration of TZP-102 on the Treatment of Symptoms Associated With Diabetic Gastroparesis (clinicaltrials.gov) - Mar 25, 2013
P2, N=201, Completed, Sponsor: Tranzyme, Inc.
N=200 --> 68 Active, not recruiting --> Completed

||||||||||  relamorelin (RM-131) / AbbVie
Trial completion:  Study to Assess Pharmacodynamics of RM-131 in Patients With Diabetic Gastroparesis (clinicaltrials.gov) -  Mar 5, 2013
P1, N=20, Completed,  Sponsor: Rhythm Pharmaceuticals, Inc.
Active, not recruiting --> Completed Recruiting --> Completed

||||||||||  erythromycin / Generic mfg.
Trial completion:  Effect of Erythromycin Before Endoscopy of Patients With Subtotal Gastrectomy (STG), High Risk of Gastric Stasis (clinicaltrials.gov) -  Feb 19, 2013
P2, N=114, Completed,  Sponsor: The Catholic University of Korea
Recruiting --> Completed Recruiting --> Completed

|||||||||| Trial termination: Diabetic Gastroparesis Efficacy/Safety Study of TZP-102 (clinicaltrials.gov) - Dec 17, 2012
P2, N=120, Terminated, Sponsor: Tranzyme, Inc.
Recruiting --> Completed Recruiting --> Terminated; Insufficient efficacy in planned interim futility analysis

|||||||||| Trial withdrawal: The Use of Domperidone for Gastroparesis (clinicaltrials.gov) - Nov 20, 2012
P3, N=0, Withdrawn, Sponsor: Allegiance Health
Recruiting --> Terminated; Insufficient efficacy in planned interim futility analysis Recruiting --> Withdrawn

|||||||||| Enrollment change: The Use of Domperidone for Gastroparesis (clinicaltrials.gov) - Nov 20, 2012
P3, N=0, Withdrawn, Sponsor: Allegiance Health
Recruiting --> Withdrawn N=30 --> 0

|||||||||| Enrollment change: Temporary Gastric Electrical Stimulation for Drug Refractory Gastroparesis (clinicaltrials.gov) - Oct 31, 2012
P3, N=58, Completed, Sponsor: University of Mississippi Medical Center
N=30 --> 0 N=40 --> 58

|||||||||| Trial completion: Temporary Gastric Electrical Stimulation for Drug Refractory Gastroparesis (clinicaltrials.gov) - Oct 31, 2012
P3, N=58, Completed, Sponsor: University of Mississippi Medical Center
N=40 --> 58 Active, not recruiting --> Completed

||||||||||  velusetrag (TD-5108) / Innoviva
New P2 trial, P2 data:  Phase 2 Study of Velusetrag in Diabetic or Idiopathic Gastroparesis (clinicaltrials.gov) -  Oct 30, 2012
P2, N=32, Active, not recruiting,  Sponsor: Theravance, Inc.

|||||||||| Trial termination: Domperidone for Relief of Gastrointestinal Disorders (clinicaltrials.gov) - Sep 10, 2012
P=N/A, N=42, Terminated, Sponsor: Carle Physician Group
Active, not recruiting --> Completed Active, not recruiting --> Terminated; PI withdrew due to increased responsibilities in clinical department.

|||||||||| Enrollment change: Domperidone for Relief of Gastrointestinal Disorders (clinicaltrials.gov) - Sep 10, 2012
P=N/A, N=42, Terminated, Sponsor: Carle Physician Group
Active, not recruiting --> Terminated; PI withdrew due to increased responsibilities in clinical department. N=80 --> 42

|||||||||| Trial completion: Pilot Study to Evaluate Magnetic Marker Imaging on Diabetic Polyneuropathy and Gastroparesis (clinicaltrials.gov) - Sep 2, 2012
P2, N=50, Completed, Sponsor: Martin-Luther-Universit
N=80 --> 42 Recruiting --> Completed

|||||||||| New P2 trial: Phase 2 Study to Evaluate the Preliminary Performance of the C13-URA Breath Test Kit in Dyspeptic Subjects (clinicaltrials.gov) - Aug 30, 2012
P2, N=36, Recruiting, Sponsor: Otsuka Pharmaceutical Co., Ltd.

|||||||||| New P2 trial: Diabetic Gastroparesis Efficacy/Safety Study of TZP-102 (clinicaltrials.gov) - Aug 12, 2012
P2, N=120, Terminated, Sponsor: Tranzyme, Inc.

|||||||||| Trial completion: Elental study: The Effect of Elemental Diet on Gastric Emptying (clinicaltrials.gov) - Aug 6, 2012
P=N/A, N=20, Completed, Sponsor: Showa Inan General Hospital
Recruiting --> Completed Recruiting --> Completed

||||||||||  erythromycin / Generic mfg.
New P2 trial:  Effect of Erythromycin Before Endoscopy of Patients With Subtotal Gastrectomy (STG), High Risk of Gastric Stasis (clinicaltrials.gov) -  Aug 6, 2012
P2, N=114, Completed,  Sponsor: The Catholic University of Korea

||||||||||  camicinal (GSK962040) / GSK
Enrollment open:  A Study to Assess the Effect of Repeat Doses of GSK962040 on the Pharmacokinetics of L-DOPA in Subjects With Parkinson's Disease Exhibiting Delayed Gastric Emptying (clinicaltrials.gov) -  Jul 25, 2012
P2, N=70, Recruiting,  Sponsor: GlaxoSmithKline
Recruiting --> Completed Not yet recruiting --> Recruiting

|||||||||| New P1/2 trial: Acupuncture Treatment for Gastroparesis: a Pilot Study (clinicaltrials.gov) - Jul 16, 2012
P1/2, N=20, Recruiting, Sponsor: Johns Hopkins University

|||||||||| New P2 trial: Pilot Study to Evaluate Magnetic Marker Imaging on Diabetic Polyneuropathy and Gastroparesis (clinicaltrials.gov) - May 28, 2012
P2, N=50, Completed, Sponsor: Martin-Luther-Universit

||||||||||  camicinal (GSK962040) / GSK
New P2 trial:  A Study to Assess the Effect of Repeat Doses of GSK962040 on the Pharmacokinetics of L-DOPA in Subjects With Parkinson's Disease Exhibiting Delayed Gastric Emptying (clinicaltrials.gov) -  May 17, 2012
P2, N=70, Recruiting,  Sponsor: GlaxoSmithKline

||||||||||  relamorelin (RM-131) / AbbVie
New P2 trial:  Phase 2 Study to Evaluate Safety & Efficacy of RM-131 Administered to Patients With Diabetic Gastroparesis (clinicaltrials.gov) -  Apr 3, 2012
P2, N=185, Active, not recruiting,  Sponsor: Rhythm Pharmaceuticals, Inc.

|||||||||| Trial withdrawal: Gastric vs Jejunal Feeding in Diabetic Gastroparesis (clinicaltrials.gov) - Apr 1, 2012
P4, N=0, Withdrawn, Sponsor: University of Zurich
Not yet recruiting --> Recruiting Not yet recruiting --> Withdrawn

|||||||||| Enrollment change: Gastric vs Jejunal Feeding in Diabetic Gastroparesis (clinicaltrials.gov) - Apr 1, 2012
P4, N=0, Withdrawn, Sponsor: University of Zurich
Not yet recruiting --> Withdrawn N=12 --> 0

||||||||||  relamorelin (RM-131) / AbbVie
Enrollment change:  Study to Assess Pharmacodynamics of RM-131 in Patients With Diabetic Gastroparesis (clinicaltrials.gov) -  Mar 22, 2012
P1, N=20, Completed,  Sponsor: Rhythm Pharmaceuticals, Inc.
N=12 --> 0 N=10 --> 20

|||||||||| Trial termination: Self-Propelled Percutaneous Endoscopic GastroJejunostomy (PEG-J) (clinicaltrials.gov) - Mar 21, 2012
P2, N=7, Terminated, Sponsor: Johns Hopkins University
N=10 --> 20 Recruiting --> Terminated; Proof of principle was achieved after inclusion of 7 patients

|||||||||| Enrollment change: Self-Propelled Percutaneous Endoscopic GastroJejunostomy (PEG-J) (clinicaltrials.gov) - Mar 21, 2012
P2, N=7, Terminated, Sponsor: Johns Hopkins University
Recruiting --> Terminated; Proof of principle was achieved after inclusion of 7 patients N=10 --> 7

||||||||||  camicinal (GSK962040) / GSK
Enrollment change:  The Effect of Single Doses of the Motilin Receptor Agonist GSK962040 in Type I Diabetic Patients With Gastroparesis (clinicaltrials.gov) -  Mar 21, 2012
P2, N=11, Completed,  Sponsor: GlaxoSmithKline
N=10 --> 7 N=18 --> 11

|||||||||| New P2 trial: Evaluation of Diagnostic Methods and Dietary Treatment of Diabetic Gastroparesis (clinicaltrials.gov) - Mar 15, 2012
P2, N=50, Recruiting, Sponsor: Göteborg University

|||||||||| New P2 trial: Self-Propelled Percutaneous Endoscopic GastroJejunostomy (PEG-J) (clinicaltrials.gov) - Mar 8, 2012
P2, N=7, Terminated, Sponsor: Johns Hopkins University

|||||||||| Trial completion: Carbon-13 (13C)-Spirulina Platensis Gastric Emptying Breath Test (GEBT) (clinicaltrials.gov) - Jan 17, 2012
P=N/A, N=30, Completed, Sponsor: Mayo Clinic
N=18 --> 11 Active, not recruiting --> Completed