Trial Outcomes & Findings for Randomized Trial of Mosapride Versus Placebo in the Treatment of Constipation-Predominant Irritable Bowel Syndrome (NCT NCT00742872)

Results Overview

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

41 participants

Primary outcome timeframe

Within the first 8 weeks of treatment

Results posted on

2013-04-09

Participant milestones
Measure	Study Mosapride Mosapride Citrate : One 5 mg tablet taken orally three times per day (15 min before meals) for 8 weeks.	Placebo Placebo 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.
Overall Study STARTED	21	20
Overall Study COMPLETED	9	12
Overall Study NOT COMPLETED	12	8

Withdrawal data not reported

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

Baseline characteristics by cohort
Measure	Study n=21 Participants Mosapride Mosapride Citrate : One 5 mg tablet taken orally three times per day (15 min before meals) for 8 weeks.	Placebo n=20 Participants Placebo 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.	Total n=41 Participants Total of all reporting groups
Age Continuous	44 years STANDARD_DEVIATION 17 • n=5 Participants	41 years STANDARD_DEVIATION 16 • n=7 Participants	43 years STANDARD_DEVIATION 16.5 • n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants	13 Participants n=7 Participants	26 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	7 Participants n=7 Participants	15 Participants n=5 Participants
Region of Enrollment Lebanon	21 participants n=5 Participants	20 participants n=7 Participants	41 participants n=5 Participants

Timeframe: Within the first 8 weeks of treatment

Outcome measures
Measure	Study n=21 Participants Mosapride Mosapride Citrate : One 5 mg tablet taken orally three times per day (15 min before meals) for 8 weeks.	Placebo n=20 Participants Placebo 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.
Adequate Relief of Symptoms Associated With Constipation-predominant Irritable Bowel Syndrome.	7 participants	10 participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adverse event data not reported

Adverse event data not reported

American University of Beirut Medical Center

Phone: +961-3-350000