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

NCT ID: NCT01576419

Last Updated: 2012-04-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 309 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2011-09-30

Brief 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

Detailed Description

Patients in the PG201 group were prescribed two PG201 tablets per day(BID) and one celecoxib placebo capsule each in the morning and evening per day for 8 weeks.

Patients in the celecoxib group were prescribed celecoxib 200 mg (one 200 mg capsule and one celecoxib placebo capsule) and one PG201 placebo tablet each in the morning and evening per day for 8 weeks.

Conditions

Osteoarthritis of the Knee

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

PG201 tablet

Group Type: EXPERIMENTAL

PG201 tablet

Intervention Type: DRUG

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

Celecoxib capsule

Group Type: ACTIVE_COMPARATOR

Celebrex capsule

Intervention Type: DRUG

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)

Interventions

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)

Intervention Type: 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)

Intervention Type: DRUG

Other Intervention Names

botanical drug; chemical drug

Eligibility Criteria

Inclusion Criteria

1. Patients ≥40 and ≤ 80years of age.

2. Patients who meet the American College of Rheumatology clinical plus radiographic classification criteria for idiopathic osteoarthritis of the knee, which are defined as follow:

a patient who had knee pain and radiographically diagnosed osteophytes and met at least one of the followings.

• Age> 50 years.
• Morning stiffness for less than 30 minutes.
• Crepitus during movement of the weight-bearing knee.

3. Patients with symptomatic primary osteoarthritis of the knee at least in the last 3 months prior to screening.

4. Patients who received Nonsteroidal antiinflammatory drugs (NSAIDs)/Cyclooxygenase-2 inhibitor for the treatment of arthritis of the knee for at least 5 days a week during 4 weeks prior to screening.

5. Patients who had a score of 100mm pain VAS ≤80 mm at screening.

6. Patients who had a score of 100mm pain VAS ≥50 mm at baseline.

7. Patients should be able and willing to provide the written informed consent.

Exclusion Criteria

1. Patients with a history of surgery or arthroscopy of the study joint within the previous 6 months.

2. Patients with trauma of study joint within the previous 12 months.

3. Patients with symptomatic hip osteoarthritis, other condition that would interfere with study assessments.

4. Patients with any other type of arthritis, active malignancies or any active GI, cardiovascular, renal, hepatic, neurologic, or psychiatric disease.

5. Patients with a known hypersensitivity or intolerance to Nonsteroidal antiinflammatory drugs (NSAIDs), aspirin or Cyclooxygenase-2 inhibitor.

6. Patients with uncontrollable hypertension.

7. Patients with any of creatinine, bilirubin, Alanine aminotransferase or Aspartate aminotransferase > 1.5 times the Upper Lange of normal at screening.

8. Patients with a history of drug or alcohol abuse.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

PMG Pharm Co., Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yeong-wook Song, MD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Wan-Hee Yoo, MD

Role: PRINCIPAL_INVESTIGATOR

Chonbuk National University Hospital

Sung-Hwan Park, MD

Role: PRINCIPAL_INVESTIGATOR

The Catholic University of Korea College of Medicine

Han-joo Baek, MD

Role: PRINCIPAL_INVESTIGATOR

Gachon University of Medicine and Science

Yun Jong Lee, MD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Bundang Hospital

Seung Cheol Shim, MD

Role: PRINCIPAL_INVESTIGATOR

Eulji University

Seong Wook Kang, MD

Role: PRINCIPAL_INVESTIGATOR

Chungnam National University School of Medicine

Hyun Ah Kim, MD

Role: PRINCIPAL_INVESTIGATOR

Hallym University Medical Center

Jung Soo Song, MD

Role: PRINCIPAL_INVESTIGATOR

Chung-Ang University Hosptial, Chung-Ang University College of Medicine

Chang Hee Suh, MD

Role: PRINCIPAL_INVESTIGATOR

Ajou University School of Medicine

Sung Jae Choi, MD

Role: PRINCIPAL_INVESTIGATOR

Korea University

Bo Young Yoon, MD

Role: PRINCIPAL_INVESTIGATOR

Inje University Ilsan Paik Hospital

Locations

Seoul National University Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

PG201-P3

Identifier Type: -

Identifier Source: org_study_id