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

Hanmi Pharmaceutical Company Limited280 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

280

Conditions

Irritable Bowel Syndrome Without Diarrhea

Interventions

Probiotics (Medirac)DRUG

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

Probiotics (Medirac)DRUG

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

Probiotics (Medirac)DRUG

15/mosapride 15mg three times a day, P.O. 4week

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

16 institutions including Gangnam Severance hospital

Seoul, South Korea

Outcomes

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.