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

NCT ID: NCT00742872

Last Updated: 2013-04-09

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-09-30
• Study Completion Date: 2010-06-30

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).

Conditions

Constipation-Predominant Irritable Bowel Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

1

Mosapride

Group Type: EXPERIMENTAL

Mosapride Citrate

Intervention Type: DRUG

One 5 mg tablet taken orally three times per day (15 min before meals) for 8 weeks.

2

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

One tablet (identical in shape and form to the actual drug) taken orally three times per day (15 min before meals) for 8 weeks.

Interventions

Mosapride Citrate

One 5 mg tablet taken orally three times per day (15 min before meals) for 8 weeks.

Intervention Type: DRUG

Placebo

One tablet (identical in shape and form to the actual drug) taken orally three times per day (15 min before meals) for 8 weeks.

Intervention Type: DRUG

Other Intervention Names

Mosar

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

American University of Beirut Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Nabil Mansour

assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ala' I. Sharara, MD

Role: PRINCIPAL_INVESTIGATOR

American University of Beirut Medical Center

Nabil M. Mansour, MD

Role: STUDY_DIRECTOR

American University of Beirut Medical Center

Locations

American University of Beirut Medical Center

Beirut, , Lebanon

Countries

Lebanon

Other Identifiers

AUB-IM.AS1.21

Identifier Type: -

Identifier Source: org_study_id