NCT01507922

Comparative Efficacy and Safety of Fenoverine

Comparative Efficacy and Safety of Fenoverine and Trimebutine Maleate in Irritable Bowel Syndrome; A Randomized Double-blind Parallel Multi-center Phase IV Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 186 (estimated)
• Sponsor: Bukwang Pharmaceutical · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Irritable Bowel Syndrome

Interventions

Type	Name	Description
DRUG	Fenoverine	Fenoverine 100mg three times a day for 8 weeks
DRUG	Timebutine	Timebutine maleate 150mg three times a day for 8 weeks

Timeline

• Start date: 2011-12-01
• Primary completion: 2013-03-01
• Completion: 2013-06-01
• First posted: 2012-01-11
• Last updated: 2014-12-18

Locations

7 sites across 1 country: South Korea