We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00742872
Recruitment Status : Terminated (Poor recruitment, high drop out rate)
First Posted : August 28, 2008
Results First Posted : April 9, 2013
Last Update Posted : April 9, 2013
Sponsor:
Information provided by (Responsible Party):
Nabil Mansour, American University of Beirut Medical Center

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).

Condition or disease Intervention/treatment Phase
Constipation-Predominant Irritable Bowel Syndrome Drug: Mosapride Citrate Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : September 2008
Primary Completion Date : June 2010
Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Constipation
U.S. FDA Resources

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. Adequate Relief of Symptoms Associated With Constipation-predominant Irritable Bowel Syndrome. [ Time Frame: Within the first 8 weeks of treatment ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: August 28, 2008    Key Record Dates
Results First Posted: April 9, 2013
Last Update Posted: April 9, 2013
Last Verified: February 2013

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

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