Comparative Efficacy and Safety of Fenoverine

• Status: Completed
• Trial end date: 2013-06-01
• Target enrollment: 0
• Participant gender: All

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 in its efficacy and safety.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bukwang Pharmaceutical
• Treatments: Fenoverine; Maleic acid; Trimebutine

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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