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

This is an interventional treatment trial for Constipation-Predominant Irritable Bowel Syndrome focused on measuring Mosapride, Irritable Bowel Syndrome, Constipation Read More

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.