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:
Hanmi Pharmaceutical Company Limited
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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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
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 Signs and Symptoms, Digestive Signs and Symptoms Colonic Diseases, Functional Colonic Diseases Intestinal Diseases Gastrointestinal Diseases Digestive System Diseases |
Mosapride Serotonin Receptor Agonists Serotonin Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Gastrointestinal Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on June 17, 2013