A Prospective Double-Blind Placebo-Controlled Trial of Mosapride in Patients With Constipation-Predominant Irritable Bowel Syndrome

American University of Beirut Medical Center1 site in 1 country41 target enrollmentSeptember 2008

ConditionsConstipation-Predominant Irritable Bowel Syndrome

InterventionsMosapride Citrate Placebo

DrugsMosapride Citrate Placebo

Overview

Phase: Phase 3
Intervention: Mosapride Citrate
Conditions: Constipation-Predominant Irritable Bowel Syndrome
Sponsor: American University of Beirut Medical Center
Enrollment: 41
Locations: 1
Primary Endpoint: Adequate Relief of Symptoms Associated With Constipation-predominant Irritable Bowel Syndrome.
Status: Terminated
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

September 2008

End Date

June 2010

Last Updated

13 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

American University of Beirut Medical Center

Responsible Party

Principal Investigator

Nabil Mansour

assistant professor

American University of Beirut Medical Center

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