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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01505777

Enrollment

280

Registered

2012-01-09

Start date

2011-05-31

Completion date

2012-06-30

Last updated

2013-04-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Irritable Bowel Syndrome Without Diarrhea

Keywords

irritable bowel syndrome without predominant diarrhea, Probiotics(Medirac) 10/mosapride 10mg, Probiotics(Medirac) 15/mosapride 10mg, Probiotics(Medirac) 15/mosapride 15mg, Probiotics(Medirac) 30/mosapride 15mg, Probiotics(Medirac) placebo/mosapride placebo

Brief summary

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

Interventions

DRUGProbiotics (Medirac)

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

DRUGProbiotics (Medirac) placebo/mosapride placebo

three times a day, P.O. 4week

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Change from Baseline in patient's overall satisfaction relief over 4 weeks of treatment of IBS symptoms	baseline and 4 week

Secondary

Measure	Time frame
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)	baseline and 4 weeks, 6 weeks

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 5, 2026