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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hanmi Pharmaceutical Company Limited
ClinicalTrials.gov Identifier:
NCT01505777
First received: January 3, 2012
Last updated: April 4, 2013
Last verified: April 2013
  Purpose

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


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Hanmi Pharmaceutical Company Limited:

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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 280
Study Start Date: May 2011
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01505777

Locations
Korea, Republic of
16 institutions including Gangnam Severance hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Hanmi Pharmaceutical Company Limited
Investigators
Principal Investigator: Hyo Jin Park, M.D., Ph.D. Gangnam Severance Hospital
  More Information

No publications provided

Responsible Party: Hanmi Pharmaceutical Company Limited
ClinicalTrials.gov Identifier: NCT01505777     History of Changes
Other Study ID Numbers: HM-MEMO-201
Study First Received: January 3, 2012
Last Updated: April 4, 2013
Health Authority: Korea: Food and Drug Administration

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

ClinicalTrials.gov processed this record on October 19, 2014