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

A Prospective Double-Blind Placebo-Controlled Trial of Mosapride in Patients With Constipation-Predominant Irritable Bowel Syndrome

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).

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.