Completed

NCT Number: NCT01505777

Exploratory Clinical Study to Evaluate the Optimal Dosage of Mosapride and Probiotics in Irritable Bowel Syndrome Without Predominant Diarrhea

The purpose of this study is to Evaluate the Optimal Dosage of Mosapride (Medirac) and Probitics in Irritable Bowel Syndrome Without Predominant Diarrhea.

Completed

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Key information

Conditions

Irritable Bowel Syndrome Without Diarrhea

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

16 institutions including Gangnam Severance hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Aged 18-75 years who satisfied RomeIII criteria for the diagnosis of IBS
Signed informed consent

Exclusion criteria

IBS-D
evidence of cathartic colon or history laxative abuse

Treatment and study plan

Probiotics (Medirac)

Drug

10/mosapride 10mg three times a day, P.O. 4week

Probiotics (Medirac) placebo/mosapride placebo

Drug

three times a day, P.O. 4week

Primary outcomes

Change from Baseline in patient's overall satisfaction relief over 4 weeks of treatment of IBS symptoms

Time frame: baseline and 4 week

Secondary outcomes

Change from Baseline in improvment of abdominal discomfort, pain, bloating, stool frequency, stool consistency, straining urgency over 4 weeks of treatment and during each week(4 weeks,6 weeks)

Time frame: baseline and 4 weeks, 6 weeks

Sponsors and collaborators

Lead sponsor

Hanmi Pharmaceutical Company Limited

Industry

Registry information

Official study title

Exploratory Clinical Study to Evaluate the Optimal Dosage of Mosapride and Probiotics in Irritable Bowel Syndrome Without Predominant Diarrhea: Double Blinded, Randomized, Placebo Drug Controlled, Parallel Designed, Multi-centered, Phase 2 Study

Important dates

Study start: 2011
Primary completion: 2012
Study completion: 2012
First posted: Jan 9, 2012
Registry last updated: Apr 5, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.