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

This study has been terminated.
(Poor recruitment, high drop out rate)
Sponsor:
Information provided by (Responsible Party):
Nabil Mansour, American University of Beirut Medical Center
ClinicalTrials.gov Identifier:
NCT00742872
First received: August 27, 2008
Last updated: February 27, 2013
Last verified: February 2013
  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 3

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

Resource links provided by NLM:


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 ]

Enrollment: 41
Study Start Date: September 2008
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Mosapride
Drug: Mosapride Citrate
One 5 mg tablet taken orally three times per day (15 min before meals) for 8 weeks.
Other Name: Mosar
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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Lebanon
American University of Beirut Medical Center
Beirut, Lebanon
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

No publications provided

Responsible Party: Nabil Mansour, assistant professor, American University of Beirut Medical Center
ClinicalTrials.gov Identifier: NCT00742872     History of Changes
Other Study ID Numbers: AUB-IM.AS1.21
Study First Received: August 27, 2008
Results First Received: February 27, 2013
Last Updated: February 27, 2013
Health Authority: Lebanon: Institutional Review Board

Keywords provided by American University of Beirut Medical Center:
Mosapride
Irritable Bowel Syndrome
Constipation

Additional relevant MeSH terms:
Irritable Bowel Syndrome
Constipation
Syndrome
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Signs and Symptoms, Digestive
Signs and Symptoms
Disease
Pathologic Processes
Mosapride
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 16, 2014