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

February 27, 2013 updated by: Nabil Mansour, American University of Beirut Medical Center

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).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

41

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Lebanon
      • Beirut, Lebanon
        • American University of Beirut Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 2
Placebo
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.
Experimental: 1
Mosapride
Drug: Mosapride Citrate
One 5 mg tablet taken orally three times per day (15 min before meals) for 8 weeks.
Other Names:
  • Mosar

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Adequate Relief of Symptoms Associated With Constipation-predominant Irritable Bowel Syndrome.
Time Frame: Within the first 8 weeks of treatment
Within the first 8 weeks of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

American University of Beirut Medical Center

Investigators

  • Study Director: Nabil M. Mansour, MD, American University of Beirut Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (Actual)

June 1, 2010

Study Completion (Actual)

June 1, 2010

Study Registration Dates

First Submitted

August 27, 2008

First Submitted That Met QC Criteria

August 27, 2008

First Posted (Estimate)

August 28, 2008

Study Record Updates

Last Update Posted (Estimate)

April 9, 2013

Last Update Submitted That Met QC Criteria

February 27, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AUB-IM.AS1.21

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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