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

This study is currently recruiting participants.

Verified by American University of Beirut Medical Center, October 2008

Sponsored by:	American University of Beirut Medical Center
Information provided by:	American University of Beirut Medical Center
ClinicalTrials.gov Identifier:	NCT00742872

Purpose

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).

Condition	Intervention	Phase
Constipation-Predominant Irritable Bowel Syndrome	Drug: Mosapride Citrate Drug: Placebo	Phase III

MedlinePlus related topics: Constipation

Drug Information available for: Citric acid Sodium Citrate Mosapride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Official Title:	A Prospective Double-Blind Placebo-Controlled Trial of Mosapride in Patients With Constipation-Predominant Irritable Bowel Syndrome

Further study details as provided by American University of Beirut Medical Center:

Primary Outcome Measures:

Adequate relief of symptoms associated with constipation-predominant irritable bowel syndrome. [ Time Frame: Within the first 8 weeks of treatment ] [ Designated as safety issue: No ]

Estimated Enrollment:	130
Study Start Date:	September 2008
Estimated Study Completion Date:	September 2010
Estimated Primary Completion Date:	September 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Mosapride	Drug: Mosapride Citrate One 5 mg tablet taken orally three times per day (15 min before meals) for 8 weeks.
2: Placebo Comparator 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.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00742872

Contacts

Contact: Ala I. Sharara, MD	+961-1-350000 ext 5345	as08@aub.edu.lb
Contact: Nabil M. Mansour, MD	+961-1-350000 ext 5405	nmansour@gmail.com

Locations

Lebanon
American University of Beirut Medical Center	Recruiting
Beirut, Lebanon
Contact: Ala' I Sharara, MD +961-1-350000 ext 5345 as08@aub.edu.lb
Contact: Nabil M Mansour, MD +961-1-350000 ext 5405 nmansour@gmail.com

Sponsors and Collaborators

American University of Beirut Medical Center

Investigators

Principal Investigator:	Ala' I. Sharara, MD	American University of Beirut Medical Center
Study Director:	Nabil M. Mansour, MD	American University of Beirut Medical Center

More Information

Responsible Party:	American University of Beirut Medical Center ( Ala' Sharara, MD, FACP, AGAF - Professor of Medicine )
Study ID Numbers:	AUB-IM.AS1.21
Study First Received:	August 27, 2008
Last Updated:	October 14, 2008
ClinicalTrials.gov Identifier:	NCT00742872
Health Authority:	Lebanon: Institutional Review Board

Keywords provided by American University of Beirut Medical Center:

Mosapride
Irritable Bowel Syndrome
Constipation

Study placed in the following topic categories:

Signs and Symptoms
Mosapride
Digestive System Diseases
Signs and Symptoms, Digestive
Gastrointestinal Diseases
Citric Acid

Colonic Diseases
Irritable Bowel Syndrome
Constipation
Intestinal Diseases
Colonic Diseases, Functional
Serotonin

Additional relevant MeSH terms:

Serotonin Agonists
Neurotransmitter Agents
Serotonin Agents
Pathologic Processes
Disease
Molecular Mechanisms of Pharmacological Action

Therapeutic Uses
Syndrome
Physiological Effects of Drugs
Gastrointestinal Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009