Clinical trial NCT01507922: Comparative Efficacy and Safety of Fenoverine
Official title: Comparative Efficacy and Safety of Fenoverine and Trimebutine Maleate in Irritable Bowel Syndrome; A Randomized Double-blind Parallel Multi-center Phase IV Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Irritable Bowel Syndrome
Keywords: Fenoverine
Irritable Bowel Syndrome
Abdominal pain
BSS
Lead sponsor: Bukwang Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2012-01-11
Enrollment: 186
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 in its efficacy and safety.

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 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.

Eligibility 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

Primary outcomes:
measure: the proportion of subjects with improvement in abdominal pain or discomfort
timeFrame: week 8
Secondary outcomes:
measure: BSS scores (each and total)
timeFrame: week 4, 8
measure: overall BSS score
timeFrame: Week 4, 8
measure: subject's satisfaction with treatment
timeFrame: week 4, 8
measure: adverse event
timeFrame: at each visit or contact until 4 weeks after the last dose
Other outcomes:
Locations:
city: Ansan
country: Korea, Republic of
facility: Korea University Ansan Hospital
city: Anyang
country: Korea, Republic of
facility: Hallym University Sacred Heart Hospital
city: Chuncheon
country: Korea, Republic of
facility: Kangwon National University Hospital
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Hospital
city: Seoul
country: Korea, Republic of
facility: Inje University Seoul Paik Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
Study officials:
affiliation: Korea University Anam Hospital
name: Yoon Tae Jeen, Dr.
role: PRINCIPAL_INVESTIGATOR
References: