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

NCT00742872 | Terminated Phase 3 Results

• 1 other identifier: AUB-IM.AS1.21
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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).

Conditions

Constipation-Predominant Irritable Bowel Syndrome

Keywords

Mosapride; Irritable Bowel Syndrome; Constipation

Outcome Measures

Primary Outcomes (1)

• Adequate Relief of Symptoms Associated With Constipation-predominant Irritable Bowel Syndrome.

  Within the first 8 weeks of treatment

Study Arms (2)

1

EXPERIMENTAL

Mosapride

Drug: Mosapride Citrate

2

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Mosapride Citrate DRUG

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

Also known as: Mosar

1

Placebo DRUG

One tablet (identical in shape and form to the actual drug) taken orally three times per day (15 min before meals) for 8 weeks.

2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• American University of Beirut Medical Center: lead

Study Sites (1)

American University of Beirut Medical Center

Beirut, Lebanon

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome; Constipation

Interventions

mosapride

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

High placebo response rate, high dropout rate.

Results Point of Contact

• Title: Dr. Ala Sharara
• Organization: American University of Beirut Medical Center

as08@aub.edu.lb

+961-3-350000

Study Officials

• Ala' I. Sharara, MD

  American University of Beirut Medical Center

  PRINCIPAL INVESTIGATOR

• Nabil M. Mansour, MD

  American University of Beirut Medical Center

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Study Record Dates

• First Submitted: August 27, 2008
• First Posted: August 28, 2008
• Study Start: September 1, 2008
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: April 9, 2013
• Results First Posted: April 9, 2013

Record last verified: 2013-02

Locations

LE (1)