CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 338 enrolled
Drug / intervention
Enteron tab. 150mg(vitis vinifera extract 150mg) : twice daily for 12 weeks +2 moredrug
Likely dose
Enteron tab. 150mg(vitis vinifera extract 150mg) : twice daily for 12 weeksfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01768520
NCT01768520Phase 3Completed

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)

Hanlim Pharm. Co., Ltd.·interventional·Posted Jan 15, 2013·Updated Jul 2, 2019

In Brief

A Phase 3 clinical trial evaluating Enteron tab. 150mg(vitis vinifera extract 150mg) : twice daily for 12 weeks, Celebrex cap. (celecoxib 200mg) : once daily, for 12 weeks, and 1 other intervention for Knee Osteoarthritis. Completed, enrolled 338 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesSouth Korea
Collaborators--

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJan 15, 2013
Enrollment StartJul 2, 2012
Primary CompletionOct 15, 2014
Study CompletionMay 13, 2015
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 13.5 years ago

Interventions

Enteron tab. 150mg(vitis vinifera extract 150mg) : twice daily for 12 weeksdrug

1. morning : 1 tab. of active Entelon 150mg plus 1 cap. of placebo Celebrex 2. evening : 1 tab. of active Entelon 150mg

Celebrex cap. (celecoxib 200mg) : once daily, for 12 weeksdrug

1. morning : 1 tab. of placebo Entelon 150mg + 1 cap. of active Celebrex 2. evening : 1 tab. of placebo Entelon 150mg

Placebodrug

1. morning : 1 tab. of placebo Entelon 150mg + 1 cap. of placebo Celebrex 2. evening : 1 tab. of placebo Entelon 150mg