Comparative Efficacy and Safety of Fenoverine

Irritable Bowel Syndrome Clinical Trial

— FEN-401  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01507922
• Other study ID #: FEN-401
• Status: Completed
• Phase: Phase 4
• First received: January 5, 2012
• Last updated: December 17, 2014
• Start date: December 2011
• Est. completion date: June 2013

Study information

• Verified date: December 2014
• Source: Bukwang Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug AdministrationKorea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 186
• Est. completion date: June 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Irritable Bowel Syndrome

Intervention

Drug:
• Fenoverine
Fenoverine 100mg three times a day for 8 weeks
• Timebutine
Timebutine maleate 150mg three times a day for 8 weeks

Locations

Country	Name	City	State
Korea, Republic of	Korea University Ansan Hospital	Ansan
Korea, Republic of	Hallym University Sacred Heart Hospital	Anyang
Korea, Republic of	Kangwon National University Hospital	Chuncheon
Korea, Republic of	Gachon University Gil Hospital	Incheon
Korea, Republic of	Inje University Seoul Paik Hospital	Seoul
Korea, Republic of	Korea University Anam Hospital	Seoul
Korea, Republic of	Korea University Guro Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Bukwang Pharmaceutical

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	subject's satisfaction with treatment	Subject's satisfaction with the treatment is measured using visual analog scale.	week 4, 8	No
Secondary	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	Yes