Exploratory Clinical Study to Evaluate the Optimal Dosage of Mosapride and Probiotics in Irritable Bowel Syndrome Without Predominant Diarrhea
April 4, 2013 updated by: Hanmi Pharmaceutical Company Limited
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
The purpose of this study is to Evaluate the Optimal Dosage of Mosapride (Medirac) and Probitics in Irritable Bowel Syndrome Without Predominant Diarrhea.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Anticipated)
280
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Seoul, Korea, Republic of
- 16 institutions including Gangnam Severance hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years to 71 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Probiotics(Medirac) 10/mosapride 10mg
|
10/mosapride 10mg three times a day, P.O.
4week
15/mosapride 10mg three times a day, P.O.
4week
15/mosapride 15mg three times a day, P.O.
4week
30/mosapride 15mg three times a day, P.O.
4week
|
|
Experimental: Probiotics(Medirac) 15/mosapride 10mg
|
10/mosapride 10mg three times a day, P.O.
4week
15/mosapride 10mg three times a day, P.O.
4week
15/mosapride 15mg three times a day, P.O.
4week
30/mosapride 15mg three times a day, P.O.
4week
|
|
Experimental: Probiotics(Medirac) 15/mosapride 15mg
|
10/mosapride 10mg three times a day, P.O.
4week
15/mosapride 10mg three times a day, P.O.
4week
15/mosapride 15mg three times a day, P.O.
4week
30/mosapride 15mg three times a day, P.O.
4week
|
|
Experimental: Probiotics(Medirac) 30/mosapride 15mg
|
10/mosapride 10mg three times a day, P.O.
4week
15/mosapride 10mg three times a day, P.O.
4week
15/mosapride 15mg three times a day, P.O.
4week
30/mosapride 15mg three times a day, P.O.
4week
|
|
Placebo Comparator: Probiotics(Medirac) placebo/mosapride placebo
|
three times a day, P.O. 4week
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change from Baseline in patient's overall satisfaction relief over 4 weeks of treatment of IBS symptoms
Time Frame: baseline and 4 week
|
baseline and 4 week
|
Secondary Outcome Measures
Outcome 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)
Time Frame: baseline and 4 weeks, 6 weeks
|
baseline and 4 weeks, 6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Hyo Jin Park, M.D., Ph.D., Gangnam Severance Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2011
Primary Completion (Actual)
June 1, 2012
Study Completion (Actual)
June 1, 2012
Study Registration Dates
First Submitted
January 3, 2012
First Submitted That Met QC Criteria
January 4, 2012
First Posted (Estimate)
January 9, 2012
Study Record Updates
Last Update Posted (Estimate)
April 5, 2013
Last Update Submitted That Met QC Criteria
April 4, 2013
Last Verified
April 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- Disease
- Signs and Symptoms, Digestive
- Gastrointestinal Diseases
- Colonic Diseases, Functional
- Colonic Diseases
- Intestinal Diseases
- Syndrome
- Irritable Bowel Syndrome
- Diarrhea
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Gastrointestinal Agents
- Serotonin Agents
- Serotonin Receptor Agonists
- Mosapride
Other Study ID Numbers
- HM-MEMO-201
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.