Exploratory Clinical Study to Evaluate the Optimal Dosage of Mosapride and Probiotics in Irritable Bowel Syndrome Without Predominant Diarrhea
1 other identifier
interventional
280
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started May 2011
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2011
CompletedFirst Submitted
Initial submission to the registry
January 3, 2012
CompletedFirst Posted
Study publicly available on registry
January 9, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2012
CompletedApril 5, 2013
April 1, 2013
1.1 years
January 3, 2012
April 4, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from Baseline in patient's overall satisfaction relief over 4 weeks of treatment of IBS symptoms
baseline and 4 week
Secondary Outcomes (1)
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
Study Arms (5)
Probiotics(Medirac) 10/mosapride 10mg
EXPERIMENTALProbiotics(Medirac) 15/mosapride 10mg
EXPERIMENTALProbiotics(Medirac) 15/mosapride 15mg
EXPERIMENTALProbiotics(Medirac) 30/mosapride 15mg
EXPERIMENTALProbiotics(Medirac) placebo/mosapride placebo
PLACEBO COMPARATORInterventions
10/mosapride 10mg three times a day, P.O. 4week
three times a day, P.O. 4week
Eligibility Criteria
You may qualify if:
- Aged 18-75 years who satisfied RomeIII criteria for the diagnosis of IBS
- Signed informed consent
You may not qualify if:
- IBS-D
- evidence of cathartic colon or history laxative abuse
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
16 institutions including Gangnam Severance hospital
Seoul, South Korea
Related Publications (1)
Choi CH, Kwon JG, Kim SK, Myung SJ, Park KS, Sohn CI, Rhee PL, Lee KJ, Lee OY, Jung HK, Jee SR, Jeen YT, Choi MG, Choi SC, Huh KC, Park H. Efficacy of combination therapy with probiotics and mosapride in patients with IBS without diarrhea: a randomized, double-blind, placebo-controlled, multicenter, phase II trial. Neurogastroenterol Motil. 2015 May;27(5):705-16. doi: 10.1111/nmo.12544. Epub 2015 Mar 25.
PMID: 25809913DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hyo Jin Park, M.D., Ph.D.
Gangnam Severance Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 3, 2012
First Posted
January 9, 2012
Study Start
May 1, 2011
Primary Completion
June 1, 2012
Study Completion
June 1, 2012
Last Updated
April 5, 2013
Record last verified: 2013-04