Randomized Trial of Mosapride Versus Placebo in the Treatment of Constipation-Predominant Irritable Bowel Syndrome
This study has been terminated.
(Poor recruitment, high drop out rate)
Sponsor:
American University of Beirut Medical Center
Information provided by (Responsible Party):
Nabil Mansour, American University of Beirut Medical Center
ClinicalTrials.gov Identifier:
NCT00742872
First received: August 27, 2008
Last updated: February 27, 2013
Last verified: February 2013
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Purpose
The purpose of this study is to determine whether Mosapride, an agent which acts on serotonin receptors in the gastrointestinal tract, is effective in the treatment of constipation-predominant irritable bowel syndrome (C-IBS).
| Condition | Intervention | Phase |
|---|---|---|
|
Constipation-Predominant Irritable Bowel Syndrome |
Drug: Mosapride Citrate Drug: Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Prospective Double-Blind Placebo-Controlled Trial of Mosapride in Patients With Constipation-Predominant Irritable Bowel Syndrome |
Resource links provided by NLM:
Further study details as provided by American University of Beirut Medical Center:
Primary Outcome Measures:
- Adequate Relief of Symptoms Associated With Constipation-predominant Irritable Bowel Syndrome. [ Time Frame: Within the first 8 weeks of treatment ] [ Designated as safety issue: No ]
| Enrollment: | 41 |
| Study Start Date: | September 2008 |
| Study Completion Date: | June 2010 |
| Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Mosapride
|
Drug: Mosapride Citrate
One 5 mg tablet taken orally three times per day (15 min before meals) for 8 weeks.
Other Name: Mosar
|
|
Placebo Comparator: 2
Placebo
|
Drug: Placebo
One tablet (identical in shape and form to the actual drug) taken orally three times per day (15 min before meals) for 8 weeks.
|
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Rome III Criteria for IBS:
Patients must have recurrent abdominal pain or discomfort at least 3 days per month during the previous 3 months that is associated with 2 or more of the following:
- Relieved by defecation
- Onset associated with a change in stool frequency
- Onset associated with a change in stool form or appearance
In addition, patients have to experience at least two of the following symptoms for at least 25% of the time [11]:
- Altered stool frequency (< 3 bowel movements per week)
- Altered stool form (lumpy/hard i.e. Bristol type I-III [see appendix 1])
- Altered stool passage (straining, urgency, or a feeling of incomplete evacuation)
- Passage of mucus, bloating, or a feeling of abdominal distension
Exclusion Criteria:
- Previous allergy to mosapride
- Nocturnal Symptoms (pain in the middle of the night, or other nocturnal symptoms which suggest an organic disease)
- Age < 18 years
- History of bloody stools or melena
- Diarrhea (>3 bowel movements per day)
- Constitutional symptoms (fever, weight loss)
- Severe constipation (< 1 bm/week)
- Pregnancy or lactation
- Patients with history of cardiac arrhythmias
- QT prolongation on baseline ECG
- Chronic laxative use and dependence
- Patients with previous history of congenital heart disease
- Patients with previous history of hypokalemia or hyperkalemia
- Patients taking the following classes of drugs: HIV antivirals, macrolides, anti-arrhythmics, and azole drugs.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00742872
Locations
| Lebanon | |
| American University of Beirut Medical Center | |
| Beirut, Lebanon | |
Sponsors and Collaborators
American University of Beirut Medical Center
Investigators
| Principal Investigator: | Ala' I. Sharara, MD | American University of Beirut Medical Center |
| Study Director: | Nabil M. Mansour, MD | American University of Beirut Medical Center |
More Information
No publications provided
| Responsible Party: | Nabil Mansour, assistant professor, American University of Beirut Medical Center |
| ClinicalTrials.gov Identifier: | NCT00742872 History of Changes |
| Other Study ID Numbers: | AUB-IM.AS1.21 |
| Study First Received: | August 27, 2008 |
| Results First Received: | February 27, 2013 |
| Last Updated: | February 27, 2013 |
| Health Authority: | Lebanon: Institutional Review Board |
Keywords provided by American University of Beirut Medical Center:
|
Mosapride Irritable Bowel Syndrome Constipation |
Additional relevant MeSH terms:
|
Constipation Irritable Bowel Syndrome Signs and Symptoms, Digestive Signs and Symptoms Colonic Diseases, Functional Colonic Diseases Intestinal Diseases Gastrointestinal Diseases Digestive System Diseases |
Mosapride Serotonin Receptor Agonists Serotonin Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Gastrointestinal Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 23, 2013