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

Constipation-Predominant Irritable Bowel Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00742872
• Other study ID #: AUB-IM.AS1.21
• Status: Terminated
• Phase: Phase 3
• First received: August 27, 2008
• Last updated: February 27, 2013
• Start date: September 2008
• Est. completion date: June 2010

Study information

• Verified date: February 2013
• Source: American University of Beirut Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Lebanon: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 41
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Constipation
• Constipation-Predominant Irritable Bowel Syndrome
• Irritable Bowel Syndrome
• Syndrome

Intervention

Drug:
• Mosapride Citrate
One 5 mg tablet taken orally three times per day (15 min before meals) for 8 weeks.
• 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.

Locations

Country	Name	City	State
Lebanon	American University of Beirut Medical Center	Beirut

Sponsors (1)

Lead Sponsor	Collaborator
American University of Beirut Medical Center

Country where clinical trial is conducted

Lebanon, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adequate Relief of Symptoms Associated With Constipation-predominant Irritable Bowel Syndrome.		Within the first 8 weeks of treatment	No