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A 13-week, multicenter, randomized, double-blind study of lumiracoxib in hip osteoarthritis

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Abstract

The aim of this 13-week, multicenter, randomized, double-blind, double-dummy, placebo- and positive-internal (celecoxib)-controlled, parallel-group study was to demonstrate the efficacy, safety, and tolerability of lumiracoxib in primary hip osteoarthritis (OA) patients. Eligible patients (n = 1,262; ACR criteria) were randomized (1:1:1) to receive lumiracoxib 100 mg once daily (o.d.) (n = 427), celecoxib 200 mg o.d. (n = 419), or matching placebo o.d. (n = 416) administered orally. The primary objective was to compare lumiracoxib 100 mg o.d. and placebo with respect to three co-primary efficacy variables: the pain subscale of the Western Ontario and McMaster Universities Osteoarthritis Index Likert version 3.1 (WOMAC™ LK 3.1) questionnaire, the function subscale of the WOMAC™ LK 3.1 questionnaire, and patient’s global assessment of disease activity (100-mm visual analog scale (VAS)) after 13 weeks of treatment. Of the 1,262 randomized patients, 951 completed the study. All randomized patients were included in the intention-to-treat and safety populations. Lumiracoxib was superior to the placebo (p < 0.001) after 13 weeks for all three co-primary endpoints. By week 13, the patient’s global assessment of disease activity (100-mm VAS) improved by 23.3 mm (±SD, 27.83 mm) with lumiracoxib and 13.3 mm (±26.71 mm) with placebo. The WOMAC™ function score decreased by 10.4 (±13.56) with lumiracoxib and 6.8 (±12.55) with placebo. The WOMAC™ pain scores decreased by 3.4 (±4.16) with lumiracoxib and 2.2 (±3.94) with placebo at week 13. Similar results were observed for secondary endpoints: OA pain intensity and WOMAC™ total score. Lumiracoxib was similar to celecoxib for all three co-primary endpoints. All treatments were well tolerated. In conclusion, lumiracoxib is effective in reducing pain and improving function in hip OA patients. Clinical trial registration information: www.clinicaltrials.gov; NCT00154219

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Abbreviations

ACR:

American College of Rheumatology

AEs:

Adverse events

ALT:

Alanine aminotransferase

ANCOVA:

Analysis of covariance

APTC:

Antiplatelet Trialists’ Collaboration

b.i.d.:

Twice daily

BOCF:

Baseline observation carried forward

BMI:

Body mass index

COX-2:

Cyclooxygenase-2

CV:

Cardiovascular

DPDA:

Difficulty in performing daily activities

GI:

Gastrointestinal

ITT:

Intention to treat

LK:

Likert scale

LOCF:

Last observation carried forward

LSMs:

Least squares means

MCII:

Minimal clinically important improvement

NSAIDs:

Nonsteroidal anti-inflammatory drugs

OA:

Osteoarthritis

OARSI:

Osteoarthritis Research Society International

o.d.:

Once daily

SAEs:

Serious adverse events

SD:

Standard deviation

TARGET:

Therapeutic Arthritis Research and Gastrointestinal Event Trial

t.i.d.:

Three times daily

ULN:

Upper limit of normal

VAS:

Visual analog scale

WOMAC™ LK 3.1:

Western Ontario and McMaster Universities Osteoarthritis Index Likert version 3.1

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Acknowledgments

We thank the investigators (see Appendix 1), the staff of the centers involved in this work, the clinical trial team for their expert collaboration, and the patients who participated in the study. The authors would also like to thank Dr. Graham Allcock, a professional medical writer with ACUMED® (Tytherington, Cheshire, UK) for his collaboration with the authors in developing an initial manuscript, and K. Ananda Krishna (Novartis, India) for providing editorial assistance in editing and incorporating subsequent revisions during the final stages of the manuscript.

Authors’ contributions

TJS, DD, BS and TM were all investigators in the study. AM was the Program Statistician, and was involved in the study design and overseeing the statistical analysis. LT was the Global Clinical Trial Leader and was involved in the study design and responsible for the trial conduct. PS was the Program Section Leader for the Phase III clinical programme. RR was medical director for the programme. All authors had access to and reviewed the data, were involved with its analysis, drafted or assisted with drafting and critical review of the manuscript, and approved the final submitted manuscript.

Sources of support

Novartis designed the study in collaboration with the independent authors. Both Novartis and the independent authors were involved in the collection, analysis, and interpretation of the data, as well as in the writing of the report and in the decision to submit the paper for publication. Novartis was the sponsor funding the role of the medical editor/writer.

Competing interests

TJS has received research grants from Genzyme, Novartis, Lilly, and Pfizer, and honoraria from Merck, Novartis, and NicOx. He has an ownership interest in NicOx and has consultancy/advisory board relationships with NicOx, Merck, and Novartis. DD has received speaking honoraria and research grants from several pharmaceutical companies including Novartis. BS and TM have no conflict of interest to declare. LT is an employee of Novartis Pharmaceuticals Corporation (East Hanover, NJ, USA). AM, PS, and RR are employees of, and own shares in, Novartis Pharma AG (Basel, Switzerland).

Author information

Authors and Affiliations

  1. Northwestern University Feinberg School of Medicine, 710 N. Lake Shore Drive, Room 1020, Chicago, IL, 60611, USA

    Thomas J. Schnitzer

  2. Prairie Clinical Research Group, University of Saskatchewan, 3310-8th Street East, Saskatoon, SK, S7H 5M3, Canada

    I. Dan Dattani

  3. Ricercatore Confermato, Clinica Reumatologica, Dipartimento Medicina Interna e Specialità Mediche, Università di Genova, Via Balbi, 5-16126, Genoa, Italy

    Bruno Seriolo

  4. Facharzt für Orthopädie/Sportmedizin, Kurstrasse 9, 61231, Bad Nauheim, Germany

    Hartmut Schneider

  5. Novartis Pharma AG, Lichtstrasse 35, 4056, Basel, Switzerland

    Alan Moore, Peter Sallstig & Rosemary Rebuli

  6. Novartis Pharmaceuticals Corporation, One Health Plaza, East Hanover, NJ, 07936, USA

    Lillian Tseng

  7. Little Common Surgery, 82 Cooden Sea Road, Little Common, Bexhill-on-Sea, East Sussex, TN39 4SP, UK

    Thomas Maxwell

  8. Departments of Physical Medicine and Rehabilitation and Internal Medicine, Northwestern University Feinberg School of Medicine, 710 N. Lake Shore Drive, Room 1020, Chicago, IL, 60611, USA

    Thomas J. Schnitzer

Authors
  1. Thomas J. Schnitzer
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  2. I. Dan Dattani
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  3. Bruno Seriolo
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  4. Hartmut Schneider
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  5. Alan Moore
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  6. Lillian Tseng
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  7. Peter Sallstig
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  8. Rosemary Rebuli
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  9. Thomas Maxwell
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Corresponding author

Correspondence to Thomas J. Schnitzer.

Appendix 1

Appendix 1

List of investigators

Canada: Dr. F. Abuzgaya, Dr. J. Lobo, Range Valley Health System, Ajax; Dr. M. Awde, Murray Awde Medicine Professional Corporation, London; Dr. A. Beaulieu, Dr. R. Therrien, Dr. P. Lachance, Centre de Rheumatologie, Quebec; Dr. W. Bensen, Dr. F. Bianchi, Charlton Medical Center, Hamilton; Dr. I.D. Dattani, Dr. S. Andres, Acadia Medical Center, Saskatoon; Dr. R. Hart, White Hills Medical Clinic, St. John’s; Dr. A. Karasik, Private Practice, Toronto; Dr. A. Kelly, Dr. W.-L. Baxter, Dr. E. Michalska, Hermitage Medical Centre, Edmonton; Dr. M. Khraishi, Dr. J. Collingwood, Dr. M. Young, St. Clare’s Mercy Hospital, St John’s; Dr. S.Y. Lam, Dr. B. Brown, Dr. P. Wong, Dr. G. Abelseth, HAWSE Clinic, Calgary; Dr. B. Lasko, Dr. S. Finkelstein, Manna Research, Toronto; Dr. J. Li, Dr. D. Landry, G.A. Research Associates Ltd., Moncton; Dr. M. Luterman, Dr. M. Csanadi, Dr. H.I. Tan-Wilson, C & L Research, Fort Erie; Dr. T. McCarthy, Dr. C. Baillie, Manitoba Clinic, Winnipeg; Dr. F. Morin, Dr. J.-L. Tremblay, Centre de Recherche Musculo-Squelettique, Trois-Rivieres; Dr. D. O’Keefe, Dr. R. Smith, Commonwealth Medical Clinic, Mount Pearl; Dr. Michael O’Mahony, Dr. M. Chivers, London Road Diagnostic Clinic and Medical Centre, Sarnia; Dr. J. Rodrigues, Private Practice, Windsor; Dr. J. Sibley, Dr. B. Nair, Dr. R. Taylor-Gjevre, Royal University Hospital, Saskatoon; Dr. A. Jaroszynska, Private Practice, Burlington; Dr. J. Carter Thorne, Dr. E. Ng, The Arthritis Program Research Group Inc., Newmarket; Dr. W. Yang, Dr. C. Shamess, Dr. J. Karsh, Ottawa Allergy Research Corporation, Ottawa; Dr. R. Zarnett, Dr. M. Clarfield, Dr. S. Coupland; Dr. I. Cohen; Dr. D. Lowe; Dr. I. Cheung, The Sports Medicine Specialists, Toronto; Dr. Brian Zidel, Dr. D. Lewis, Dr. M. Buchstein, Dr. K. Thakkar, Dr. C. Palad, Dr. K. Marshall, Dr. S. Black, Dr. S. Brown, Malton Medical Centre, Mississauga; Dr. A. Chow, Dr. E. Soucy, Credit Valley Professional Bldg., Mississauga; Dr. N. Aggarwal, Dr. L. Manacki, Dr. H. Earle, Aggarwal and Associates, Brampton; Dr. D. Spink, Dr. J. Goodge, Brookdale Research Inc., Peterborough; Dr. L. van den Berg, Dr. J.Tenebaum, Can-Med Clinical Research, Victoria; Dr. Y.-D. Gagnon, Dr. M. Pouliot, Clinique Médicale du Boisé, Langevin; Dr. N. Roy, Dr. P. Rheault, Dr. T. Pella, MediCor Research, Sudbury; Dr. D. Callaghan, Private Practice, Hamilton; Dr. S. Day, Glover Medical Clinic, Langley; Dr. P. Dzongowski, London East Medical Centre, London; Dr. G. Marotta, Gerontion Research Inc., Toronto; Dr. W. O’Mahony, Corunna Research Centre, Corunna; Dr. J. Tannenbaum, Meadowlands Family Health Center, Ottawa; Dr. I. Teitelbaum, Private Practice, Toronto; Dr. M. Tolszczuk, Q&T Research, Inc., Sherbrooke; Dr. M. Lafreniere, Clinique Medicale Pierre Bertrand, Vanier; Dr. G. Tellier, Zoom International Saint-Jerome; Dr. B. Carlson, North Road Medical Centre, Coquitlam; Dr. S. Coyle, Misericordia Health Centre, Winnipeg

Germany: Dr. med. A. Herzner, Dr. S. Mindt-Pruefert, Dr. med. D. Zuechner, Dr. med. M. Mehrwald, Klinische Forschung Hamburg, Hamburg; Dr. med. R. Heller, Prof. Dr. H.-G. Dammann, Dr. med. A. Herzner, Dr. med. S. Schafer, Klinische Forschung Schwerin, Schwerin; Ms. S. Laus, Dr. S. Schulze, Klinische Forschung Berlin Mitte, Berlin; Dr. med. R. Lehmann, Dr. A. Khariouzov; Dr. E. Tanis-Ziegler, Dr. L. Stratmann, Klinische Forschung Berlin-Buch GmbH, Berlin; Dr. med. A. Becker, Praxis Dr. Becker, Woelfersheim; Dr. med. R. Malek, Dr. M Malex, Praxis Dr. Malek, Frankfurt; Dr. R. Willburger, Dr. K. Johannigmann, St. Elisabeth Hospital, Bochum; Dr. med. J. Hettwer, Praxis Dr. Hettwer, Bad Hersfeld; Dr. med. J. Chevts, Praxis Dr. Chevts, Karlsruhe; Dr. med. H. Schneider, Praxis Dr. Schneider, Messkirch; Dr. med. H., Schneider, Praxis Dr. Schneider, Bad Nauheim; Prof. Dr. med. J. Hensen, Dr. M. Hickstein, Dr. T. Thomas, Staedt. Kankenhaus Nordstadt, Hannover; Dr. med. A. Holst, Dr. med. C. Grigat, Dr. med. R. Martz, Clinical Research, Hamburg; Prof. Dr. F. Emmrich, Dipl med. O. Maus, Dr. V. Matthaeus, Zentrum f. Therapiestudien, Leipzig; Dr. med. W. Pohl, Praxis Dr. Pohl, Dresden; Dr. med. M. Kuetemeyer, Praxis Dr. Kuetemeyer, Bammental; Dr. med. D. Popa, Praxis Dr. Popa, Veitsbronn; Dr. med. H. Samer, Praxis Dr. Samer, Haag; Dr. med. C. Bauknecht, Praxis Dr. Bauknecht, Rottweil; Dr. med. J. Hock, Praxis Dr. Hock, Freisen-Oberkirchen; Dr. med. M. Hartard, Dr. J. Koburg, Dr. D. Hartard, Technische Universitaet Muenchen, Muenchen; Dr. D. Rau, Praxis Dr. Rau, Pinneberg; Prof. Dr. med. J. Grifka, Dr. med. S. Werber, Orthopaedische Klinik, Bad Abbach; Dr. med. J. Mey, Praxis Dr. Mey, Dortmund; Dr. med. U. Gerbaulet, Praxis Dr. Gerbaulet/Dr. Biesenbaum, Loehne; Dr. med. G. Dahmen, Dr. A. Dahmen, Ms. S. Tegethoff, Ms. U. Schroeder, Praxis Dr. Dahmen/Dr. Schiewe, Hamburg; Dr. med. E. Borbas, Praxis Dr. Borbas, Muenster; Dr. med. M. Thuma, Dr. med. O. Heibült, Praxis Dr. Thuma, Berlin; Dr. med. H. Seibert, Praxis Dr. Seibert, Kassel; Dipl Med R. Nischik, Ms. K. Schubert, Medamed Studienambulanz, Leipzig

Italy: Dr. G. Bianchi, Dr. V. Siccardi, Dr. ssa M. Calamai, Dr. M. Ponte, Dr. S. Anfossi, Dr. G. Girasole, Sig.ra C. Giusto, Az. San. Genovese 3 P.O., Genova Ponente – S.O. La Colletta, Arenzano; Prof. C. Borghi, Dr. ssa R. Mulè, Dr. ssa N. Malavolta, Dr. ssa G. Vukatana, Az. Osp. di Bologna Policl. S. Orsola – Malpighi, Bologna; Prof. M. Matucci Cerinic, Dr. ssa F. Nacci, Dr. ssa C. Marinotti, Dr. ssa F. Bartoli, Azienda Ospedaliera Careggi–Università degli Studi, Firenze; Prof. B. Seriolo, Dr. V. Ferretti, Dr. ssa D. Fasciolo, Dr. ssa S. Paolino, Az. Osp. Ospedale S. Martino–Università degli Studi, Genova; Prof. G. Rovetta, Dr. ssa T. Maio, Dr. ssa M. Olivieri, Istituto E. Bruzzone, Genova; Prof. W. Grassi, Dr. ssa P. Blasetti, Dr. ssa A. Farina, Presidio Ospedaliero Ospedale, Murri, Jesi; Prof. U. Martorana, Dr. R. Arcidiacono, Azienda Ospedaliera, Universitaria Policlinico P. Giaccone, Palermo; Prof. E. Mannarino, Dr. ssa L. Scarponi, Dr. C. Leli, Dr. G. Fabbriciani, Ospedale Regionale Silvestrini–Università degli Studi, S. Andrea delle Fratte; Dr. L. Di Matteo, Dr. ssa A. Verrocchio, Dr. R. Zicolella, Dr. L. Di Battista, Ospedale Civile dello Spirito Santo, Pescara; Prof. S. Bombardieri, Dr. ssa L. Bazzichi, Dr. ssa T. Giuliano, Azienda Ospedaliera Ospedali, Riuniti S. Chiara; Pisa; Prof. Salvatore Minisola, Dr. ssa S. De Geronimo, Dr. ssa E. Romagnoli, Azienda Policlinico Umberto I–Università La Sapienza, Roma; Prof. S. Adami, Dr. ssa V. Braga, Dr. ssa I. Lippolis, Dr. ssa O. Viapiana, Dr. ssa J. Bakrì, Dr. ssa L. Rizzardi, Centro Ospedaliero Clinicizzato di Medicina Riab. e Prev., Valeggio

United Kingdom: Dr. R. Sarmiento, Synexus Ltd., Edgbaston, Birmingham; Dr. S. Taylor, Dr. M. Thomson, Chorley Synexus Ltd., Chorley; Dr. H. Shaw, Reading Clinical Research Centre, Reading; Dr. J. Robinson, Dr. J. Fraser, Dr. C. Godfrey, Synexus Ltd., Wigan; Dr. H. Thomas, Dr. J. Vickers, Dr. A. Stevenson, Synexus Ltd., Cardiff; Dr. I. Pavel, Dr. M. Khursheed, Dr. H. Lewis Jones, Dr. G.H.R. Lamb, Synexus Ltd., Crosby Clinical Research Centre, Waterloo, Liverpool; Dr. T. Maxwell, Little Common Surgery, Bexhill-on-Sea

United States of America: Dr. C. Danning, Dr. G. Fiocco, Dr. P. Valen, Gundersen Lutheran Hospital and Clinics, LaCrosse, WI; Dr. J. Farrell, S. Brunk, C. Berner, C.Turnbough, Midwest Pharmaceutical Research, Inc., St. Peters, MO; Dr. M. Feinman, Arthritis and Osteoporosis Center, Orangeburg, SC; Dr. M. Goldberg, Dr. B. Schaetman, Dr. I. Foxall, New Jersey Physicians, LLC, Passaic, NJ; Dr. R. Jimenez, A. Solomon, J. Peterson, Edmonds Rheumatology Associates, Edmonds, WA; Dr. N. Mohan, Dr. J. Fanciullo, Mrs. J. Warren-Kittlesrud, Mrs. S. Baumgart-Weaver, North Central Kidney Institute, Avera Research, Sioux Falls, SD; Dr. J. Booth, Dr. J. Mijer, Dr. G. Biddulph, Dr. J. Call, Physician’s Research Options, LC, Ogden, UT; Dr. A. McCain, Dr. L. Jones, Texas Research Center, Sugar Land, TX; Dr. W. Shergy, Dr. R. Phillips Jr., Dr. R. Hunt, Dr. J. Hernandez, Rheumatology Associates of North Alabama, Huntsville, AL; Dr. H. Marker, Memphis Medical Associates, Memphis, TN; Dr. B. Samuels, Dr. T. 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Schnitzer, T.J., Dattani, I.D., Seriolo, B. et al. A 13-week, multicenter, randomized, double-blind study of lumiracoxib in hip osteoarthritis. Clin Rheumatol 30, 1433–1446 (2011). https://doi.org/10.1007/s10067-011-1776-4

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