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

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

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

Study Overview

• Status: Completed
• Conditions: Osteoarthritis of the Knee
• Intervention / Treatment: Drug: PG201 tablet; Drug: Celebrex capsule

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.

• Study Type: Interventional
• Enrollment (Actual): 309
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PG201 tablet	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); Other Names: botanical drug
Active Comparator: Celecoxib capsule	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); Other Names: chemical drug

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
100mm Pain VAS reduction	Screening, Day1, Day28

Secondary Outcome Measures

Outcome Measure	Time Frame
Pain VAS total score on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)	Screening, Day1, Day28
Sub-scale score and total score on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)	Screening, Day1, Day28
The change in the quality of life score	Day1, Day28
The change in the patient self-assessed & investigator-assessed overall symptom scores	Screening, Day1, Day28
The responder index (RI)	screening, Day1, Day28

Collaborators and Investigators

• Sponsor: PMG Pharm Co., Ltd
• Investigators: Principal Investigator: Yeong-wook Song, MD, Seoul National University Hospital; Principal Investigator: Wan-Hee Yoo, MD, Chonbuk National University Hospital; Principal Investigator: Sung-Hwan Park, MD, The Catholic University of Korea College of Medicine; Principal Investigator: Han-joo Baek, MD, Gachon University of Medicine and Science; Principal Investigator: Yun Jong Lee, MD, Seoul National University Bundang Hospital; Principal Investigator: Seung Cheol Shim, MD, Eulji University; Principal Investigator: Seong Wook Kang, MD, Chungnam National University School of Medicine; Principal Investigator: Hyun Ah Kim, MD, Hallym University Medical Center; Principal Investigator: Jung Soo Song, MD, Chung-Ang University Hosptial, Chung-Ang University College of Medicine; Principal Investigator: Chang Hee Suh, MD, Ajou University School of Medicine; Principal Investigator: Sung Jae Choi, MD, Korea University; Principal Investigator: Bo Young Yoon, MD, Inje University Ilsan Paik Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Actual): March 1, 2011
• Study Completion (Actual): September 1, 2011

Study Registration Dates

• First Submitted: April 4, 2012
• First Submitted That Met QC Criteria: April 10, 2012
• First Posted (Estimate): April 12, 2012

Study Record Updates

• Last Update Posted (Estimate): April 12, 2012
• Last Update Submitted That Met QC Criteria: April 10, 2012
• Last Verified: April 1, 2012

More Information

Terms related to this study

• Keywords: Non-inferiority; 100mm pain VAS; PG201
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Cyclooxygenase 2 Inhibitors; Celecoxib
• Other Study ID Numbers: PG201-P3