NCT01576419

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 309 (actual)
• Sponsor: PMG Pharm Co., Ltd · Industry
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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)
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)

Timeline

• Start date: 2010-01-01
• Primary completion: 2011-03-01
• Completion: 2011-09-01
• First posted: 2012-04-12
• Last updated: 2012-04-12

Locations

1 site across 1 country: South Korea