Comparative Efficacy and Safety of Fenoverine (FEN-401)

Bukwang Pharmaceutical

Status and phase

Completed

Phase 4

Conditions

Irritable Bowel Syndrome

Treatments

Drug: Timebutine

Drug: Fenoverine

Study type

Interventional

Funder types

Industry

Identifiers

NCT01507922

FEN-401

Details and patient eligibility

About

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.

Full 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 capsule and the other is tablet, double dummy design will be used. Efficacy is evaluated at the end of 8 weeks and safety will be followed for 4 more weeks after the end of the scheduled medication.

Enrollment

186 estimated patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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