Comparative Efficacy and Safety of Fenoverine

Study Overview
=================
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.

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

Conditions
-----------------
Irritable Bowel Syndrome

Intervention / Treatment
-----------------
* Drug: Fenoverine
* Drug: Timebutine


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fenoverine<br>Fenoverine 100mg three times a day will be administered for 8 weeks. | Drug: Fenoverine<br>* Fenoverine 100mg three times a day for 8 weeks<br>* Other names: Fexadin;|
| Active Comparator: Trimebutine<br>Trimebutine maleate 150mg three times a day will be administered for 8 weeks. | Drug: Timebutine<br>* Timebutine maleate 150mg three times a day for 8 weeks<br>* Other names: Polybutin;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the proportion of subjects with improvement in abdominal pain or discomfort | the proportion of subjects who experienced more than 30% improvement in abdominal pain or discomfort score with visual analog scale at week 8 compared to baseline | week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BSS scores (each and total) | BSS score will be checked for four IBS symptoms; abdominal pain or discomfort, bloating, constipation, diarrhea. The scores will be compared for its chronological changes between trial groups. Total BSS score will be the sum of the scores of four symptoms measured. | week 4, 8 | 
| overall BSS score | IBS symptom will be assessed overally by subjects at day 1, week 4, and week 8. The scores will be compared chronologically between groups. | Week 4, 8 | 
| subject's satisfaction with treatment | Subject's satisfaction with the treatment is measured using visual analog scale. | week 4, 8 | 
| adverse event | Vital signs will be checked at each visit. Laboratory tests will be conducted at baseline and week 8, and at any time if necessary. | at each visit or contact until 4 weeks after the last dose | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fenoverine, Irritable Bowel Syndrome, Abdominal pain, BSS