Status:
COMPLETED
Comparative Efficacy and Safety of Fenoverine
Lead Sponsor:
Bukwang Pharmaceutical
Conditions:
Irritable Bowel Syndrome
Eligibility:
All Genders
18-60 years
Phase:
PHASE4
Brief Summary
It is a randomized double-blind parallel phase IV study to compare Fenoverine and Trimebutine maleate in the efficacy and safety. Study Hypothesis: Fenoverine is non-inferior to Trimebutine maleate i...
Detailed Description
For subjects with IBS, Fenoverine and Trimebutine will be administered orally for 8 weeks; Fenoverine 100mg capsule three times a day and Trimebutine 150mg tablet three times a day. Because one is cap...
Eligibility Criteria
Inclusion
- 18 years of age or older and 60 years of age or younger
- Diagnosed as irritable bowel syndrome using Rome III Criteria
- Female subjects of child-bearing potential are confirmed to have a negative urine beta-hCG test within 7 days prior to administration of initial dose of investigational products.
- Female subjects of child-bearing potential must agree to use contraceptive measures during study period.
Exclusion
- Known allergy or hypersensitivity to investigational products or components of the formulation
- Past or current diagnosis of chronic liver disease (e.g., liver cirrhosis, acute hepatitis, alcoholic hepatitis, chronic alcohol abuse and HCC)
- Past or current diagnosis of Myopathy
- Subject with serious renal disease
- Known medical condition assessed by investigators as inappropriate for the study
- Continuous use of NSAIDS, analgesics, steroids, or other immunosuppressants.
- Continuous use of HMG-CoA reductase inhibitors or fibrates to lower blood lipid level
- Pregnant, lactating, or planning to be pregnant women
- Evidence of abuse of drugs or alcohol within 6 months prior to screening
- Participation in other clinical trials within 3 months prior to enrollment or elapse of less than 5 half lives of previous investigational product after last dose of it.
- Unable to submit informed consent or comply with the requirements of the study
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2013
Estimated Enrollment :
186 Patients enrolled
Trial Details
Trial ID
NCT01507922
Start Date
December 1 2011
End Date
June 1 2013
Last Update
December 18 2014
Active Locations (7)
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1
Korea University Ansan Hospital
Ansan, South Korea
2
Hallym University Sacred Heart Hospital
Anyang, South Korea
3
Kangwon National University Hospital
Chuncheon, South Korea
4
Gachon University Gil Hospital
Incheon, South Korea