Exploratory Clinical Study to Evaluate the Optimal Dosage of Mosapride and Probiotics in Irritable Bowel Syndrome Without Predominant Diarrhea
Phase 2
Completed
- Conditions
- Irritable Bowel Syndrome Without Diarrhea
- Interventions
- Drug: Probiotics (Medirac)Drug: Probiotics (Medirac) placebo/mosapride placebo
- Registration Number
- NCT01505777
- Lead Sponsor
- Hanmi Pharmaceutical Company Limited
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 280
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Probiotics(Medirac) 10/mosapride 10mg Probiotics (Medirac) - Probiotics(Medirac) 15/mosapride 10mg Probiotics (Medirac) - Probiotics(Medirac) 15/mosapride 15mg Probiotics (Medirac) - Probiotics(Medirac) 30/mosapride 15mg Probiotics (Medirac) - Probiotics(Medirac) placebo/mosapride placebo Probiotics (Medirac) placebo/mosapride placebo -
- Primary Outcome Measures
Name Time Method Change from Baseline in patient's overall satisfaction relief over 4 weeks of treatment of IBS symptoms baseline and 4 week
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
16 institutions including Gangnam Severance hospital
🇰🇷Seoul, Korea, Republic of