Randomized Trial of Mosapride Versus Placebo in the Treatment of Constipation-Predominant Irritable Bowel Syndrome

Phase 3

Terminated

• Conditions: Constipation-Predominant Irritable Bowel Syndrome
• Interventions: Drug: Mosapride Citrate; Drug: Placebo

• Registration Number: NCT00742872
• Lead Sponsor: American University of Beirut Medical Center

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-08-27
• Study First Submitted QC: 2008-08-27
• Study First Posted: 2008-08-28
• Study Start: 2008-09
• Primary Completion: 2010-06
• Study Completion: 2010-06
• Status Verified: 2013-02
• Results First Submitted: 2013-02-27
• Results First Submitted QC: 2013-02-27
• Last Update Submitted: 2013-02-27
• Results First Posted: 2013-04-09
• Last Update Posted: 2013-04-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 41

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Mosapride Citrate	Mosapride
2	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
Adequate Relief of Symptoms Associated With Constipation-predominant Irritable Bowel Syndrome.	Within the first 8 weeks of treatment

Trial Locations

Locations (1)

American University of Beirut Medical Center; 🇱🇧 Beirut, Lebanon