NCT01768520

Evaluation of the Efficacy and Safety of Entelon Tab. 150mg in Patients With Osteoarthritis of Knee

For 12 Weeks, the Multi-center, Randomized, Double-blinded, Clinical Study to Evaluate the Efficacy and Safety of Entelon Tab. 150mg Compared With Celebrex Capsule in Patients With Osteoarthritis of Knee (Phase III)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 338 (actual)
• Sponsor: Hanlim Pharm. Co., Ltd. · Industry
• Sex: All
• Age: 35 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This clinical trial is planned to prove Entelon tab. arm is not inferior to Celebrex cap. arm in terms of the efficacy and safety through the change of K-WOMAC's total score sum in patients with osteoarthritis of knee.

Conditions

• Knee Osteoarthritis

Interventions

Type	Name	Description
DRUG	Enteron tab. 150mg(vitis vinifera extract 150mg) : twice daily for 12 weeks	1. morning : 1 tab. of active Entelon 150mg plus 1 cap. of placebo Celebrex 2. evening : 1 tab. of active Entelon 150mg
DRUG	Celebrex cap. (celecoxib 200mg) : once daily, for 12 weeks	1. morning : 1 tab. of placebo Entelon 150mg + 1 cap. of active Celebrex 2. evening : 1 tab. of placebo Entelon 150mg
DRUG	Placebo	1. morning : 1 tab. of placebo Entelon 150mg + 1 cap. of placebo Celebrex 2. evening : 1 tab. of placebo Entelon 150mg

Timeline

• Start date: 2012-07-02
• Primary completion: 2014-10-15
• Completion: 2015-05-13
• First posted: 2013-01-15
• Last updated: 2019-07-02
• Results posted: 2019-06-24

Locations

1 site across 1 country: South Korea