Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
186 participants
INTERVENTIONAL
2011-12-31
2013-06-30
Brief Summary
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Study Hypothesis: Fenoverine is non-inferior to Trimebutine maleate in its efficacy and safety.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Fenoverine
Fenoverine 100mg three times a day will be administered for 8 weeks.
Fenoverine
Fenoverine 100mg three times a day for 8 weeks
Trimebutine
Trimebutine maleate 150mg three times a day will be administered for 8 weeks.
Timebutine
Timebutine maleate 150mg three times a day for 8 weeks
Interventions
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Fenoverine
Fenoverine 100mg three times a day for 8 weeks
Timebutine
Timebutine maleate 150mg three times a day for 8 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 Years
60 Years
ALL
No
Sponsors
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Bukwang Pharmaceutical
INDUSTRY
Responsible Party
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Principal Investigators
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Yoon Tae Jeen, Dr.
Role: PRINCIPAL_INVESTIGATOR
Korea University Anam Hospital
Locations
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Korea University Ansan Hospital
Ansan, , South Korea
Hallym University Sacred Heart Hospital
Anyang, , South Korea
Kangwon National University Hospital
Chuncheon, , South Korea
Gachon University Gil Hospital
Incheon, , South Korea
Inje University Seoul Paik Hospital
Seoul, , South Korea
Korea University Anam Hospital
Seoul, , South Korea
Korea University Guro Hospital
Seoul, , South Korea
Countries
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Other Identifiers
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FEN-401
Identifier Type: -
Identifier Source: org_study_id