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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
PMG Pharm Co., Ltd
ClinicalTrials.gov Identifier:
NCT01576419
First received: April 4, 2012
Last updated: April 10, 2012
Last verified: April 2012
  Purpose

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


Condition Intervention Phase
Osteoarthritis of the Knee
Drug: PG201 tablet
Drug: Celebrex capsule
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Double Blinded, Randomized, Active Drug Comparative, Multi-center, phase3 Clinical Study to Evaluate the Efficacy and Safety of PG201 in Osteoarthritis Patients

Resource links provided by NLM:


Further study details as provided by PMG Pharm Co., Ltd:

Primary Outcome Measures:
  • 100mm Pain VAS reduction [ Time Frame: Screening, Day1, Day28 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pain VAS total score on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) [ Time Frame: Screening, Day1, Day28 ] [ Designated as safety issue: No ]
  • Sub-scale score and total score on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) [ Time Frame: Screening, Day1, Day28 ] [ Designated as safety issue: No ]
  • The change in the quality of life score [ Time Frame: Day1, Day28 ] [ Designated as safety issue: No ]
  • The change in the patient self-assessed & investigator-assessed overall symptom scores [ Time Frame: Screening, Day1, Day28 ] [ Designated as safety issue: No ]
  • The responder index (RI) [ Time Frame: screening, Day1, Day28 ] [ Designated as safety issue: No ]

Enrollment: 309
Study Start Date: January 2010
Study Completion Date: September 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: chemical drug

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.

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01576419

Locations
Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
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 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
  More Information

No publications provided

Responsible Party: PMG Pharm Co., Ltd
ClinicalTrials.gov Identifier: NCT01576419     History of Changes
Other Study ID Numbers: PG201-P3
Study First Received: April 4, 2012
Last Updated: April 10, 2012
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by PMG Pharm Co., Ltd:
PG201
Non-inferiority
100mm pain VAS

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Celecoxib
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Therapeutic Uses
Central Nervous System Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on July 24, 2014