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

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ClinicalTrials.gov Identifier: NCT01505777
Recruitment Status : Completed
First Posted : January 9, 2012
Last Update Posted : April 5, 2013
Sponsor:
Information provided by (Responsible Party):

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

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
Primary Completion Date : June 2012
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 :
  1. 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 :
  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) [ Time Frame: baseline and 4 weeks, 6 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
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
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hanmi Pharmaceutical Company Limited
ClinicalTrials.gov Identifier: NCT01505777     History of Changes
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:
Syndrome
Diarrhea
Irritable Bowel Syndrome
Disease
Pathologic Processes
Signs and Symptoms, Digestive
Signs and Symptoms
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