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

• Status: Terminated
• Trial end date: 2010-06-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: American University of Beirut Medical Center
• Treatments: Mosapride

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.