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Original Article

Fixed-dose combination of enteric-coated naproxen and immediate-release esomeprazole has comparable efficacy to celecoxib for knee osteoarthritis: two randomized trials

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Pages 1243-1253 | Accepted 08 Apr 2011, Published online: 28 Apr 2011

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Read on this site (9)

Robert J. Holt, John G. Fort, Amy Y. Grahn, Jeffrey D. Kent & Alfonso E. Bello. (2015) Onset and durability of pain relief in knee osteoarthritis: Pooled results from two placebo trials of naproxen/esomeprazole combination and celecoxib. The Physician and Sportsmedicine 43:3, pages 200-212.
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Allan Gibofsky, Marc C. Hochberg, Mark J. Jaros & Clarence L. Young. (2014) Efficacy and safety of low-dose submicron diclofenac for the treatment of osteoarthritis pain: a 12 week, phase 3 study. Current Medical Research and Opinion 30:9, pages 1883-1893.
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Jeffery D. Kent, Robert J. Holt, Donald Jung, George F. Tidmarsh, Amy Y. Grahn, Julie Ball & David A. Peura. (2014) Pharmacodynamic evaluation of intragastric pH and implications for famotidine dosing in the prophylaxis of non-steroidal anti-inflammatory drug induced gastropathy—a proof of concept analysis. Journal of Drug Assessment 3:1, pages 20-27.
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Catherine Datto, Richard Hellmund & Mohd Kashif Siddiqui. (2013) Efficacy and tolerability of naproxen/esomeprazole magnesium tablets compared with non-specific NSAIDs and COX-2 inhibitors: a systematic review and network analyses. Open Access Rheumatology: Research and Reviews 5, pages 1-19.
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Roy Altman, Stephen Daniels & Clarence L. Young. (2013) Indomethacin Submicron Particle Capsules Provide Effective Pain Relief in Patients with Acute Pain: A Phase 3 Study. The Physician and Sportsmedicine 41:4, pages 7-15.
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Allan Gibofsky, Stephen Silberstein, Charles Argoff, Stephen Daniels, Steve Jensen & Clarence L. Young. (2013) Lower-Dose Diclofenac Submicron Particle Capsules Provide Early and Sustained Acute Patient Pain Relief in a Phase 3 Study. Postgraduate Medicine 125:5, pages 130-138.
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Bill McCarberg & Penny Tenzer. (2013) Complexities in the pharmacologic management of osteoarthritis pain. Current Medical Research and Opinion 29:5, pages 539-548.
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Sanford H. Roth & Shane Anderson. (2011) The NSAID Dilemma: Managing Osteoarthritis in High-Risk Patients. The Physician and Sportsmedicine 39:3, pages 62-74.
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Articles from other publishers (36)

Mart A. F. J. van de Laar, Rainer Schöfl, Marlou Prevoo & Jan Jastorff. (2023) Predictive value of gastrointestinal symptoms and patient risk factors for NSAID-associated gastrointestinal ulcers defined by endoscopy? Insights from a pooled analysis of two naproxen clinical trials. PLOS ONE 18:4, pages e0284358.
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Joseph Pergolizzi, Giustino Varrassi, Jo Ann K LeQuang, Frank Breve & Peter Magnusson. (2023) Fixed Dose Versus Loose Dose: Analgesic Combinations. Cureus.
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Yura Kim, Gregory Levin, Nikolay P. Nikolov, Robert Abugov & Rebecca Rothwell. (2022) Concept End Points Informing Design Considerations for Confirmatory Clinical Trials in Osteoarthritis. Arthritis Care & Research 74:7, pages 1154-1162.
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Hyungdon Kook, Cheol Woong Yu, Donghoon Choi, Tae Hoon Ahn, Kiyuk Chang, Jin-Man Cho, Soo-Joong Kim, Chang Gyu Park, Deok-Kyu Cho, Sang-Hyun Kim, Han Cheol Lee, Han-Young Jin, In-Ho Chae, Kihwan Kwon, Sung Gyun Ahn, Ju Han Kim, Sang-Rok Lee, Jeong-Su Kim, Seok Yeon Kim & Sang Wook Lim. (2022) Efficacy and Safety of SID142 in Patients With Peripheral Arterial Disease: A Multicenter, Randomized, Double-Blind, Active-Controlled, Parallel-Group, Phase III Clinical Trial. Clinical Therapeutics 44:4, pages 508-528.
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Dong-Wook Kim & Kwon Yeon Weon. (2021) Pharmaceutical application and development of fixed-dose combination: dosage form review. Journal of Pharmaceutical Investigation 51:5, pages 555-570.
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Man Soo Kim, In Jun Koh, Yong Gyu Sung, Dong Chul Park, Sung Cheol Yang & Yong In. (2021) Efficacy and safety of celecoxib combined with JOINS in the treatment of degenerative knee osteoarthritis: study protocol of a randomized controlled trial. Therapeutic Advances in Musculoskeletal Disease 13, pages 1759720X2110240.
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Rex Park, Anthony M.-H. Ho, Gisele Pickering, Lars Arendt-Nielsen, Mohammed Mohiuddin & Ian Gilron. (2020) Efficacy and Safety of Magnesium for the Management of Chronic Pain in Adults: A Systematic Review. Anesthesia & Analgesia 131:3, pages 764-775.
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M.V. Bielsa-Fernández, J.L. Tamayo-de la Cuesta, J. Lizárraga-López, J.M. Remes-Troche, R. Carmona-Sánchez, J.M. Aldana-Ledesma, J.M. Avendaño-Reyes, M.A. Ballesteros-Amozorrutia, M. De Ariño, L. de Giau-Triulzi, R. Flores-Rendón, H. Huerta-Guerrero, J.A. González-González, A. Hernández-Guerrero, E. Murcio-Pérez, J. Jáquez-Quintana, A. Meixueiro-Daza, J.R. Nogueira-de Rojas, H. Rodríguez-Hernández, R. Santoyo-Valenzuela, S.C. Solorzano-Olmos, L.F. Uscanga-Domínguez & F. Zamarripa-Dorsey. (2020) The Mexican consensus on the diagnosis, treatment, and prevention of NSAID-induced gastropathy and enteropathy. Revista de Gastroenterología de México (English Edition) 85:2, pages 190-206.
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M.V. Bielsa-Fernández, J.L. Tamayo-de la Cuesta, J. Lizárraga-López, J.M. Remes-Troche, R. Carmona-Sánchez, J.M. Aldana-Ledesma, J.M. Avendaño-Reyes, M.A. Ballesteros-Amozorrutia, M. De Ariño, L. de Giau-Triulzi, R. Flores-Rendón, H. Huerta-Guerrero, J.A. González-González, A. Hernández-Guerrero, E. Murcio-Pérez, J.O. Jáquez-Quintana, A. Meixueiro-Daza, J.R. Nogueira-de Rojas, H. Rodríguez-Hernández, R. Santoyo-Valenzuela, S.C. Solorzano-Olmos, L.F. Uscanga-Domínguez & F. Zamarripa-Dorsey. (2020) Consenso mexicano sobre diagnóstico, prevención y tratamiento de la gastropatía y enteropatía por antiinflamatorios no esteroideos. Revista de Gastroenterología de México 85:2, pages 190-206.
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Min-Gyue Park, Jae-Doo Yoo & Kyu-Ho Lee. (2020) Current Guidelines for Non-Steroidal Anti-Inflammatory Drugs. Journal of the Korean Orthopaedic Association 55:1, pages 9.
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Daehyun ParkYonguk Kwon. (2020) Factors Affecting Quality of Life and Satisfaction in Patients with Arthritis after Change to a Fixed-Dose Naproxen/Esomeprazole Combination Drug. Clinics in Orthopedic Surgery 12:1, pages 86.
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Claire L. Smith, Yan Jin, Eyas Raddad, Terry A. McNearney, Xiao Ni, David Monteith, Roger Brown, Mark A. Deeg & Thomas Schnitzer. (2019) Applications of Bayesian statistical methodology to clinical trial design: A case study of a phase 2 trial with an interim futility assessment in patients with knee osteoarthritis. Pharmaceutical Statistics 18:1, pages 39-53.
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Daniel Sowah, Flora Balat & Sebastian Straube. (2018) Work-related outcomes in randomized, double blind, placebo-controlled trials in osteoarthritis – are they adequately reported in journal publications? A systematic review. Journal of Occupational Medicine and Toxicology 13:1.
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Y. Jin, C. Smith, D. Monteith, R. Brown, A. Camporeale, T.A. McNearney, M.A. Deeg, E. Raddad, N. Xiao, A. de la Peña, A.J. Kivitz & T.J. Schnitzer. (2018) CGRP blockade by galcanezumab was not associated with reductions in signs and symptoms of knee osteoarthritis in a randomized clinical trial. Osteoarthritis and Cartilage 26:12, pages 1609-1618.
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Emma L Parry, Martin J Thomas & George Peat. (2018) Defining acute flares in knee osteoarthritis: a systematic review. BMJ Open 8:7, pages e019804.
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David S. Jevsevar, Peter B. Shores, Kyle Mullen, Danielle M. Schulte, Gregory A. Brown & Deborah S. Cummins. (2018) Mixed Treatment Comparisons for Nonsurgical Treatment of Knee Osteoarthritis: A Network Meta-analysis. Journal of the American Academy of Orthopaedic Surgeons 26:9, pages 325-336.
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Marita Cross, Ludovic Dubouis, Matthieu Mangin, David J. Hunter, Lyn March, Gillian Hawker & Francis Guillemin. (2017) Defining Flare in Osteoarthritis of the Hip and Knee: A Systematic Literature Review — OMERACT Virtual Special Interest Group. The Journal of Rheumatology 44:12, pages 1920-1927.
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Tie P. Yamato, Chris G. Maher, Bruno T. Saragiotto, Christina Abdel Shaheed, Anne M. Moseley, Chung-Wei Christine Lin, Bart Koes & Andrew J. McLachlan. (2017) Comparison of effect sizes between enriched and nonenriched trials of analgesics for chronic musculoskeletal pain: a systematic review. British Journal of Clinical Pharmacology 83:11, pages 2347-2355.
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Cheuk-Yui Leung, Andrea N. Trementozzi, Yiqing Lin, Jin Xu, Erwin Irdam, J. Michael MacPhee, Min He, Shyam B. Karki, Pierre Boulas & Peter N. Zawaneh. (2017) Enteric coating of micron-size drug particles through a Würster fluid-bed process. Powder Technology 317, pages 247-252.
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Livia Puljak, Ana Marin, Davorka Vrdoljak, Filipa Markotic, Ana Utrobicic & Peter Tugwell. (2017) Celecoxib for osteoarthritis. Cochrane Database of Systematic Reviews 2017:7.
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Chul-Won Ha, Yong-Beom Park, Hee-Soo Kyung, Chung-Soo Han, Ki-Cheor Bae, Hong-Chul Lim, Sang-Eun Park, Myung Chul Lee, Ye-Yeon Won, Dong-Chul Lee, Sung-Do Cho, Chang-Wan Kim, Jin-Goo Kim, Joon-Soon Kang, Ju-Hong Lee, Eui-Sung Choi, Jong-Keun Seon, Woo-Suk Lee & Seong-Il Bin. (2016) Gastrointestinal safety and efficacy of long-term GCSB-5 use in patients with osteoarthritis: A 24-week, multicenter study. Journal of Ethnopharmacology 189, pages 310-318.
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Chao Xu, Ke Gu, Yalikun Yasen & Yanjie Hou. (2016) Efficacy and Safety of Celecoxib Therapy in Osteoarthritis. Medicine 95:20, pages e3585.
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Carmelo Scarpignato, Angel Lanas, Corrado Blandizzi, Willem F Lems, Matthias Hermann & Richard H Hunt. (2015) Safe prescribing of non-steroidal anti-inflammatory drugs in patients with osteoarthritis – an expert consensus addressing benefits as well as gastrointestinal and cardiovascular risks. BMC Medicine 13:1.
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Bill H. McCarberg & Byron Cryer. (2015) Evolving Therapeutic Strategies to Improve Nonsteroidal Anti-inflammatory Drug Safety. American Journal of Therapeutics 22:6, pages e167-e178.
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Marc C Hochberg. (2015) Response to: ‘Is chondroitin sulfate plus glucosamine superior to placebo in the treatment of knee osteoarthritis?’ by Zeng et al . Annals of the Rheumatic Diseases 74:9, pages e57-e57.
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Chao Zeng, Jie Wei, Hui Li, Tuo Yang, Shu-guang Gao, Yu-sheng Li, Yi-lin Xiong, Wen-feng Xiao, Wei Luo, Tu-bao Yang & Guang-hua Lei. (2015) Comparison between 200 mg QD and 100 mg BID oral celecoxib in the treatment of knee or hip osteoarthritis. Scientific Reports 5:1.
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Dominick J. Angiolillo, Catherine Datto, Shane Raines & Neville D. Yeomans. (2013) Impact of concomitant low-dose aspirin on the safety and tolerability of naproxen and esomeprazole magnesium delayed-release tablets in patients requiring chronic nonsteroidal anti-inflammatory drug therapy: an analysis from 5 Phase III studies. Journal of Thrombosis and Thrombolysis 38:1, pages 11-23.
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Yong-Geun Park, Chul-Won Ha, Chang-Dong Han, Seong-Il Bin, Hee-Chun Kim, Young-Bok Jung & Hong-Chul Lim. (2013) A prospective, randomized, double-blind, multicenter comparative study on the safety and efficacy of Celecoxib and GCSB-5, dried extracts of six herbs, for the treatment of osteoarthritis of knee joint. Journal of Ethnopharmacology 149:3, pages 816-824.
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Katherine A. Lyseng-Williamson & Sohita Dhillon. (2012) Fixed-dose naproxen/esomeprazole magnesium: a guide to its use to treat arthritic symptoms and reduce gastric ulcer risk. Drugs & Therapy Perspectives 28:8, pages 1-5.
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Robin K Dore & Megan Locks. (2012) Naproxen/esomeprazole magnesium in the treatment of osteoarthritis, rheumatoid arthritis and ankylosing spondylitis. International Journal of Clinical Rheumatology 7:1, pages 21-31.
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