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.

Abstract

The objectives of the study are to demonstrate the non-inferiority of PG201

(Layla((R))) 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.