Comparative Efficacy and Safety of Fenoverine
- Registration Number
- NCT01507922
- Lead Sponsor
- Bukwang Pharmaceutical
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 186
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Fenoverine Fenoverine Fenoverine 100mg three times a day will be administered for 8 weeks. Trimebutine Timebutine Trimebutine maleate 150mg three times a day will be administered for 8 weeks.
- Primary Outcome Measures
Name Time Method the proportion of subjects with improvement in abdominal pain or discomfort week 8 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
- Secondary Outcome Measures
Name Time Method BSS scores (each and total) week 4, 8 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.
overall BSS score Week 4, 8 IBS symptom will be assessed overally by subjects at day 1, week 4, and week 8. The scores will be compared chronologically between groups.
subject's satisfaction with treatment week 4, 8 Subject's satisfaction with the treatment is measured using visual analog scale.
adverse event at each visit or contact until 4 weeks after the last dose Vital signs will be checked at each visit. Laboratory tests will be conducted at baseline and week 8, and at any time if necessary.
Trial Locations
- Locations (7)
Gachon University Gil Hospital
🇰🇷Incheon, Korea, Republic of
Kangwon National University Hospital
🇰🇷Chuncheon, Korea, Republic of
Hallym University Sacred Heart Hospital
🇰🇷Anyang, Korea, Republic of
Korea University Guro Hospital
🇰🇷Seoul, Korea, Republic of
Korea University Ansan Hospital
🇰🇷Ansan, Korea, Republic of
Inje University Seoul Paik Hospital
🇰🇷Seoul, Korea, Republic of
Korea University Anam Hospital
🇰🇷Seoul, Korea, Republic of