NCT01743287

The Study to Evaluate Efficacy and Safety of Imotun Capsule in Osteoarthritis of the Knee

A Six-month, Multi Center, Randomized, Double Blind, Parallel-group, Placebo Controlled Study to Evaluate Efficacy and Safety of Imotun Capsule in Osteoarthritis of the Knee

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 234 (actual)
• Sponsor: Chong Kun Dang Pharmaceutical · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate efficacy and safety of Imotun capsule in osteoarthritis of the knee

Detailed description

This is a six-month, multicenter, randomized, double blind, parallel-group,placebo controlled study. Patients take Imotun capsules or placebo once a day, between the meals. Patients are allowed to take study drugs during the meal in the case of intolerant reflux of oil smell from GI. If patients do not tolerate the pain, they are able to take Celecoxib as a rescue medication during 6 months.

Conditions

• Osteoarthritis of the Knee

Interventions

Type	Name	Description
DRUG	Imotun capsule	Imotun capsule: Avocado-Soya Unsaponifiables 300.03mg/Cap, per oral, a capsule once a day during for 24 weeks
DRUG	Imotun capsule placebo	Imotun capsule placebo: per oral, a capsule a day during 24 weeks

Timeline

• Start date: 2012-12-01
• Primary completion: 2015-04-01
• Completion: 2015-04-01
• First posted: 2012-12-06
• Last updated: 2015-04-30

Locations

10 sites across 1 country: South Korea