Irritable Bowel Syndrome
Conditions
Keywords
Fenoverine, Irritable Bowel Syndrome, Abdominal pain, BSS
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.
Interventions
DRUGFenoverine
Fenoverine 100mg three times a day for 8 weeks
DRUGTimebutine
Timebutine maleate 150mg three times a day for 8 weeks
Sponsors
Bukwang Pharmaceutical
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
South Korea
Outcome results
None listed