title: 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(®)) 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.
authors: Department of Internal Medicine, Medical School, Chonbuk National University, Jeonju, Korea, ywhim@chonbuk.ac.kr.
authors: Wan-Hee
authors: WH
authors: Yoo
authors: Han-Gyul
authors: HG
authors: Yoo
authors: Sung-Hwan
authors: SH
authors: Park
authors: Han-Joo
authors: HJ
authors: Baek
authors: Yun Jong
authors: YJ
authors: Lee
authors: Seung Cheol
authors: SC
authors: Shim
authors: Seong Wook
authors: SW
authors: Kang
authors: Hyun Ah
authors: HA
authors: Kim
authors: Jung Soo
authors: JS
authors: Song
authors: Chang Hee
authors: CH
authors: Suh
authors: Sung Jae
authors: SJ
authors: Choi
authors: Bo Young
authors: BY
authors: Yoon
authors: Dong Nyeon
authors: DN
authors: Tae
authors: Hyun Sook
authors: HS
authors: Ko
authors: Yeong-Wook
authors: YW
authors: Song
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000068579:Celecoxib; D052246:Cyclooxygenase 2 Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D020370:Osteoarthritis, Knee / Q000188:drug therapy*; D010147:Pain Measurement; D010936:Plant Extracts / Q000009:adverse effects / Q000627:therapeutic use*; D011720:Pyrazoles / Q000009:adverse effects / Q000627:therapeutic use*; D011788:Quality of Life; D013449:Sulfonamides / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D052246:Cyclooxygenase 2 Inhibitors; D010936:Plant Extracts; D011720:Pyrazoles; D013449:Sulfonamides; C476094:herbal extract PG201; D000068579:Celecoxib