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
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
309
One PG201 tablet and one celecoxib placebo capsule(after breakfast, in 30minutes), One PG201 tablet and one celecoxib placebo capsule(after dinner, in 30minutes)
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)
Seoul National University Hospital
Seoul, South Korea
100mm Pain VAS reduction
Time frame: Screening, Day1, Day28
Pain VAS total score on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time frame: Screening, Day1, Day28
Sub-scale score and total score on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time frame: Screening, Day1, Day28
The change in the quality of life score
Time frame: Day1, Day28
The change in the patient self-assessed & investigator-assessed overall symptom scores
Time frame: Screening, Day1, Day28
The responder index (RI)
Time frame: screening, Day1, Day28
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