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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

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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.

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Acknowledgments

This clinical study was supported in part by R&D Center of PMG Pharm Co., Ltd. The authors would like to thank Mi-Hyun Cho, Seok-Min Yoon of ADM Korea Inc. (CRO) and Hae-Kwan Eo, Young-Chin Chun of PMG Pharm Co., Ltd.

Conflict of interest

The authors declare that they have no conflicts of interest concerning this article.

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Authors and Affiliations

  1. Department of Internal Medicine, Medical School, Chonbuk National University, Jeonju, Korea

    Wan-Hee Yoo

  2. Research Institute of Clinical Medicine, Chonbuk National University Hospital, Chonbuk National University, Jeonju, Korea

    Wan-Hee Yoo

  3. Department of Pharmacy Practice, University of Rhode Island, Kingston, RI, 02881, USA

    Han-Gyul Yoo

  4. College of Medicine, The Catholic University of Korea, Seoul, Korea

    Sung-Hwan Park

  5. Gachon University of Medicine and Science, Incheon, Korea

    Han-joo Baek

  6. Bundang Hospital, Seoul National University, Seoul, Korea

    Yun Jong Lee

  7. School of Medicine, Eulji University, Daejeon, Korea

    Seung Cheol Shim

  8. School of Medicine, Chungnam National University, Daejeon, Korea

    Seong Wook Kang

  9. Sacred Heart Hospital, Hallym University, Anyang, Korea

    Hyun Ah Kim

  10. College of Medicine, Chung-Ang University, Seoul, Korea

    Jung Soo Song

  11. School of Medicine, Ajou University, Suwon, Korea

    Chang Hee Suh

  12. College of Medicine, Korea University, Ansan, Korea

    Sung Jae Choi

  13. Ilsan Paik Hospital, Inje University, Goyang, Korea

    Bo Young Yoon

  14. PMG Pharm Co, Ltd., Ansan, Korea

    Dong Nyeon Tae & Hyun Sook Ko

  15. Department of Internal Medicine, Seoul National University Hospital, 28 Yeongeon-dong, Jongno-gu, Seoul, 110-744, Korea

    Yeong-Wook Song

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  1. Wan-Hee Yoo
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Correspondence to Yeong-Wook Song.

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Yoo, WH., Yoo, HG., Park, SH. et al. 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. Rheumatol Int 34, 1369–1378 (2014). https://doi.org/10.1007/s00296-014-2964-8

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  • DOI: https://doi.org/10.1007/s00296-014-2964-8

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