search
Back to results

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

Primary Purpose

Irritable Bowel Syndrome Without Diarrhea

Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Probiotics (Medirac)
Probiotics (Medirac)
Probiotics (Medirac)
Probiotics (Medirac)
Probiotics (Medirac) placebo/mosapride placebo
Sponsored by
Hanmi Pharmaceutical Company Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Irritable Bowel Syndrome Without Diarrhea focused on measuring 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

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • 16 institutions including Gangnam Severance hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

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

Arm Description

Outcomes

Primary Outcome Measures

Change from Baseline in patient's overall satisfaction relief over 4 weeks of treatment of IBS symptoms

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)

Full Information

First Posted
January 3, 2012
Last Updated
April 4, 2013
Sponsor
Hanmi Pharmaceutical Company Limited
search

1. Study Identification

Unique Protocol Identification Number
NCT01505777
Brief Title
Exploratory Clinical Study to Evaluate the Optimal Dosage of Mosapride and Probiotics in Irritable Bowel Syndrome Without Predominant Diarrhea
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 Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hanmi Pharmaceutical Company Limited

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome Without Diarrhea
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
280 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Probiotics(Medirac) 10/mosapride 10mg
Arm Type
Experimental
Arm Title
Probiotics(Medirac) 15/mosapride 10mg
Arm Type
Experimental
Arm Title
Probiotics(Medirac) 15/mosapride 15mg
Arm Type
Experimental
Arm Title
Probiotics(Medirac) 30/mosapride 15mg
Arm Type
Experimental
Arm Title
Probiotics(Medirac) placebo/mosapride placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Probiotics (Medirac)
Intervention Description
10/mosapride 10mg three times a day, P.O. 4week
Intervention Type
Drug
Intervention Name(s)
Probiotics (Medirac)
Intervention Description
15/mosapride 10mg three times a day, P.O. 4week
Intervention Type
Drug
Intervention Name(s)
Probiotics (Medirac)
Intervention Description
15/mosapride 15mg three times a day, P.O. 4week
Intervention Type
Drug
Intervention Name(s)
Probiotics (Medirac)
Intervention Description
30/mosapride 15mg three times a day, P.O. 4week
Intervention Type
Drug
Intervention Name(s)
Probiotics (Medirac) placebo/mosapride placebo
Intervention Description
three times a day, P.O. 4week
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hyo Jin Park, M.D., Ph.D.
Organizational Affiliation
Gangnam Severance Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
16 institutions including Gangnam Severance hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
25809913
Citation
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs