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

Irritable Bowel Syndrome Without Diarrhea Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01505777
• Other study ID #: HM-MEMO-201
• Status: Completed
• Phase: Phase 2
• First received: January 3, 2012
• Last updated: April 4, 2013
• Start date: May 2011
• Est. completion date: June 2012

Study information

• Verified date: April 2013
• Source: Hanmi Pharmaceutical Company Limited
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 280
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diarrhea
• Irritable Bowel Syndrome
• Irritable Bowel Syndrome Without Diarrhea
• Syndrome

Intervention

Drug:
• Probiotics (Medirac)
10/mosapride 10mg three times a day, P.O. 4week
• Probiotics (Medirac)
15/mosapride 10mg three times a day, P.O. 4week
• Probiotics (Medirac)
15/mosapride 15mg three times a day, P.O. 4week
• Probiotics (Medirac)
30/mosapride 15mg three times a day, P.O. 4week
• Probiotics (Medirac) placebo/mosapride placebo
three times a day, P.O. 4week

Locations

Country	Name	City	State
Korea, Republic of	16 institutions including Gangnam Severance hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Hanmi Pharmaceutical Company Limited

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in patient's overall satisfaction relief over 4 weeks of treatment of IBS symptoms		baseline and 4 week	No
Secondary	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	No