Efficacy and safety of PG201 (Layla(®)) and celecoxib in the treatment of
symptomatic knee osteoarthritis: a double-blinded, randomized, multi-center,
active drug comparative, parallel-group, non-inferiority, phase III study.
Author(s): Yoo WH(1), Yoo HG, Park SH, Baek HJ, Lee YJ, Shim SC, Kang SW, Kim HA, Song JS,
Suh CH, Choi SJ, Yoon BY, Tae DN, Ko HS, Song YW.
Affiliation(s): Author information:
(1)Department of Internal Medicine, Medical School, Chonbuk National University,
Jeonju, Korea, ywhim@chonbuk.ac.kr.
Publication date & source: 2014, Rheumatol Int. , 34(10):1369-78
The objectives of the study are to demonstrate the non-inferiority of PG201
(Layla(®)) 600 mg in comparison with celecoxib 200 mg for the treatment of
symptomatic knee osteoarthritis (OA). In total, 309 patients were randomly
assigned to receive either the test drug, PG201 600 mg (n = 154) or celecoxib 200
mg (n = 155). The primary efficacy variable was improvement in mean 100-mm pain
VAS score from baseline to the final visit (week 8), and this value was compared
between the 2 treatment groups. Secondary outcome variables included changes from
baseline in the Western Ontario and McMaster Universities Arthritis Index (WOMAC)
pain VAS score and subscale score, patient's global assessment of disease status
quality of life (short form-36) and responder index at weeks 4 and 8. For safety
assessment, adverse events were recorded at each clinical visit. At weeks 8, the
100-mm pain VAS scores were significantly decreased in patients receiving both
PG201 600 mg (p < 0.0001) and celecoxib 200 mg (p < 0.0001) as compared to the
baseline scores; however, no statistically significant differences in these
values were noted between the groups (p = 0.312). These results met pre-specified
criteria for non-inferiority for both the intent-to-treat and per-protocol
populations. PG201 600 mg and celecoxib 200 mg were both well tolerated and no
statistically significant differences in the tolerability profile between the
groups. PG201 600 mg was as effective and safe as celecoxib 200 mg in the
treatment of symptomatic knee OA and might be a useful new medication for the
treatment of symptomatic knee OA.
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