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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT01505777

Recruitment Status : Completed

First Posted : January 9, 2012

Last Update Posted : April 5, 2013

Sponsor:

Information provided by (Responsible Party):

Hanmi Pharmaceutical Company Limited

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Irritable Bowel Syndrome Without Diarrhea	Drug: Probiotics (Medirac) Drug: Probiotics (Medirac) placebo/mosapride placebo	Phase 2

Study Design

Layout table for study information

Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	280 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double (Participant, Investigator)
Primary Purpose:	Treatment
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
Study Start Date :	May 2011
Actual Primary Completion Date :	June 2012
Actual Study Completion Date :	June 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diarrhea

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: Probiotics(Medirac) 10/mosapride 10mg	Drug: Probiotics (Medirac) 10/mosapride 10mg three times a day, P.O. 4week
Experimental: Probiotics(Medirac) 15/mosapride 10mg	Drug: Probiotics (Medirac) 15/mosapride 10mg three times a day, P.O. 4week
Experimental: Probiotics(Medirac) 15/mosapride 15mg	Drug: Probiotics (Medirac) 15/mosapride 15mg three times a day, P.O. 4week
Experimental: Probiotics(Medirac) 30/mosapride 15mg	Drug: Probiotics (Medirac) 30/mosapride 15mg three times a day, P.O. 4week
Placebo Comparator: Probiotics(Medirac) placebo/mosapride placebo	Drug: Probiotics (Medirac) placebo/mosapride placebo three times a day, P.O. 4week

Outcome Measures

Primary Outcome Measures :

Change from Baseline in patient's overall satisfaction relief over 4 weeks of treatment of IBS symptoms [ Time Frame: baseline and 4 week ]

Secondary Outcome Measures :

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 ]

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information

Ages Eligible for Study:	18 Years to 75 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01505777

Locations

Layout table for location information

Korea, Republic of
16 institutions including Gangnam Severance hospital
Seoul, Korea, Republic of

Sponsors and Collaborators

Hanmi Pharmaceutical Company Limited

Investigators

Layout table for investigator information

Principal Investigator:	Hyo Jin Park, M.D., Ph.D.	Gangnam Severance Hospital

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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. Erratum in: Neurogastroenterol Motil. 2015 Nov;27(11):1684-5. Dosage error in article text.

Layout table for additonal information

Responsible Party:	Hanmi Pharmaceutical Company Limited
ClinicalTrials.gov Identifier:	NCT01505777
Other Study ID Numbers:	HM-MEMO-201
First Posted:	January 9, 2012 Key Record Dates
Last Update Posted:	April 5, 2013
Last Verified:	April 2013

Keywords provided by Hanmi Pharmaceutical Company Limited:


irritable bowel syndrome without predominant diarrhea Probiotics(Medirac) 10/mosapride 10mg Probiotics(Medirac) 15/mosapride 10mg	Probiotics(Medirac) 15/mosapride 15mg Probiotics(Medirac) 30/mosapride 15mg Probiotics(Medirac) placebo/mosapride placebo

Additional relevant MeSH terms:

Layout table for MeSH terms

Irritable Bowel Syndrome Syndrome Diarrhea Disease Pathologic Processes Signs and Symptoms, Digestive Colonic Diseases, Functional Colonic Diseases Intestinal Diseases	Gastrointestinal Diseases Digestive System Diseases Mosapride Gastrointestinal Agents Serotonin Receptor Agonists Serotonin Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs

To Top