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

Osteoarthritis of the Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01576419
• Other study ID #: PG201-P3
• Status: Completed
• Phase: Phase 3
• First received: April 4, 2012
• Last updated: April 10, 2012
• Start date: January 2010
• Est. completion date: September 2011

Study information

• Verified date: April 2012
• Source: PMG Pharm Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 309
• Est. completion date: September 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis of the Knee
• Osteoarthritis, Knee

Intervention

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)
• 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)

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
PMG Pharm Co., Ltd

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	100mm Pain VAS reduction		Screening, Day1, Day28	No
Secondary	Pain VAS total score on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)		Screening, Day1, Day28	No
Secondary	Sub-scale score and total score on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)		Screening, Day1, Day28	No
Secondary	The change in the quality of life score		Day1, Day28	No
Secondary	The change in the patient self-assessed & investigator-assessed overall symptom scores		Screening, Day1, Day28	No
Secondary	The responder index (RI)		screening, Day1, Day28	No