Active Drug Comparative, Multi-center, phase3 Clinical Study to Evaluate the Efficacy and Safety of PG201 in Osteoarthritis Patients

Summary

The objective of this study was to to evaluate the efficacy and safety of PG201 in osteoarthritis patients.

This clinical study was designated to be non-inferiority test with level of significance: 95%, α=0.05. Type 2 error (β) was set as 0.2, and the power of the test was set as 80%. Assuming 20% drop-out rate, the number of subjects required for each treatment group was estimated to be 154, while the total number of subjects required for the study 308.

non-inferiority margin: 8mm

Conditions

• Osteoarthritis of the Knee

Interventions

DRUG

PG201 tablet

One PG201 tablet and one celecoxib placebo capsule(after breakfast, in 30minutes), One PG201 tablet and one celecoxib placebo capsule(after dinner, in 30minutes)

DRUG

Celebrex capsule

One celecoxib capsule and one PG201 placebo tablet(after breakfast, in 30minutes), one celecoxib placebo capsule and one PG201 placebo tablet(after dinner, in 30minutes)

Sponsors & Collaborators

• PMG Pharm Co., Ltd

  lead INDUSTRY

Principal Investigators

• Yeong-wook Song, MD · Seoul National University Hospital

• Wan-Hee Yoo, MD · Chonbuk National University Hospital

• Sung-Hwan Park, MD · The Catholic University of Korea College of Medicine

• Han-joo Baek, MD · Gachon University of Medicine and Science

• Yun Jong Lee, MD · Seoul National University Bundang Hospital

• Seung Cheol Shim, MD · Eulji University

• Seong Wook Kang, MD · Chungnam National University School of Medicine

• Hyun Ah Kim, MD · Hallym University Medical Center

• Jung Soo Song, MD · Chung-Ang University Hosptial, Chung-Ang University College of Medicine

• Chang Hee Suh, MD · Ajou University School of Medicine

• Sung Jae Choi, MD · Korea University

• Bo Young Yoon, MD · Inje University Ilsan Paik Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

40 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-01-31

Primary Completion

2011-03-31

Completion

2011-09-30

Countries

• South Korea

Study Locations