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

American University of Beirut Medical Center

Status and phase: Terminated; Phase 3

Conditions: Constipation-Predominant Irritable Bowel Syndrome

Treatments: Drug: Placebo; Drug: Mosapride Citrate

Study type: Interventional

Funder types: Other

Identifiers

NCT00742872

AUB-IM.AS1.21

Details and patient eligibility

About

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).

Enrollment: 41 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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41 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

Mosapride

Treatment:

Drug: Mosapride Citrate

2

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo