Comparative Efficacy and Safety of Fenoverine

NCT01507922 | Completed Phase 4

• 1 other identifier: FEN-401
• Study Type: interventional
• Target: 186
• Locations: 1 country
• Sites: 7

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.

Conditions

Irritable Bowel Syndrome

Keywords

Fenoverine; Irritable Bowel Syndrome; Abdominal pain; BSS

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• BSS scores (each and total)

  week 4, 8

• overall BSS score

  Week 4, 8

• subject's satisfaction with treatment

  week 4, 8

• adverse event

  at each visit or contact until 4 weeks after the last dose

Study Arms (2)

Fenoverine

EXPERIMENTAL

Fenoverine 100mg three times a day will be administered for 8 weeks.

Drug: Fenoverine

Trimebutine

ACTIVE COMPARATOR

Trimebutine maleate 150mg three times a day will be administered for 8 weeks.

Drug: Timebutine

Interventions

Fenoverine DRUG

Fenoverine 100mg three times a day for 8 weeks

Also known as: Fexadin

Fenoverine

Timebutine DRUG

Timebutine maleate 150mg three times a day for 8 weeks

Also known as: Polybutin

Trimebutine

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Bukwang Pharmaceutical: lead

Study Sites (7)

Korea University Ansan Hospital

Ansan, South Korea

Location

Hallym University Sacred Heart Hospital

Anyang, South Korea

Location

Kangwon National University Hospital

Chuncheon, South Korea

Location

Gachon University Gil Hospital

Incheon, South Korea

Location

Inje University Seoul Paik Hospital

Seoul, South Korea

Location

Korea University Anam Hospital

Seoul, South Korea

Location

Korea University Guro Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome; Abdominal Pain

Interventions

fenoverine

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive

Study Officials

• Yoon Tae Jeen, Dr.

  Korea University Anam Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2012
• First Posted: January 11, 2012
• Study Start: December 1, 2011
• Primary Completion: March 1, 2013
• Study Completion: June 1, 2013
• Last Updated: December 18, 2014

Record last verified: 2014-12

Locations

KR (7)