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

NCT01576419 | Completed Phase 3 DMC

• 1 other identifier: PG201-P3
• Study Type: interventional
• Target: 309
• Locations: 1 country
• Sites: 1

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

Conditions

Osteoarthritis of the Knee

Keywords

PG201; Non-inferiority; 100mm pain VAS

Outcome Measures

Primary Outcomes (1)

• 100mm Pain VAS reduction

  Screening, Day1, Day28

Secondary Outcomes (5)

• 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

Study Arms (2)

PG201 tablet

EXPERIMENTAL

Drug: PG201 tablet

Celecoxib capsule

ACTIVE COMPARATOR

Drug: Celebrex capsule

Interventions

PG201 tablet 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)

Also known as: botanical drug

PG201 tablet

Celebrex capsule 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)

Also known as: chemical drug

Celecoxib capsule

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients ≥40 and ≤ 80years of age.
• 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.
• Patients with symptomatic primary osteoarthritis of the knee at least in the last 3 months prior to screening.
• 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.
• Patients who had a score of 100mm pain VAS ≤80 mm at screening.
• Patients who had a score of 100mm pain VAS ≥50 mm at baseline.
• Patients should be able and willing to provide the written informed consent.

You may not qualify if:

• Patients with a history of surgery or arthroscopy of the study joint within the previous 6 months.
• Patients with trauma of study joint within the previous 12 months.
• Patients with symptomatic hip osteoarthritis, other condition that would interfere with study assessments.
• Patients with any other type of arthritis, active malignancies or any active GI, cardiovascular, renal, hepatic, neurologic, or psychiatric disease.
• Patients with a known hypersensitivity or intolerance to Nonsteroidal antiinflammatory drugs (NSAIDs), aspirin or Cyclooxygenase-2 inhibitor.
• Patients with uncontrollable hypertension.
• Patients with any of creatinine, bilirubin, Alanine aminotransferase or Aspartate aminotransferase \> 1.5 times the Upper Lange of normal at screening.
• Patients with a history of drug or alcohol abuse.

Sponsors & Collaborators

• PMG Pharm Co., Ltd: lead

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

herbal extract PG201; Celecoxib; Drug Contamination

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Public Health; Environment and Public Health

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2012
• First Posted: April 12, 2012
• Study Start: January 1, 2010
• Primary Completion: March 1, 2011
• Study Completion: September 1, 2011
• Last Updated: April 12, 2012

Record last verified: 2012-04

Locations

KR (1)