Table of Contents Author Guidelines Submit a Manuscript
Pain Research and Treatment
Volume 2011 (2011), Article ID 239501, 9 pages
http://dx.doi.org/10.1155/2011/239501
Clinical Study

A Phase IIIb, Multicentre, Randomised, Parallel-Group, Placebo-Controlled, Double-Blind Study to Investigate the Efficacy and Safety of OROS Hydromorphone in Subjects with Moderate-to-Severe Chronic Pain Induced by Osteoarthritis of the Hip or the Knee

1Orthos Paidion, 83263 Bratislava, Slovakia
2Dianthus Medical Limited, London SW19 2RL, UK
3EMEA Medical Affairs, Analgesia, Janssen-Cilag, Quarryvale, Co Dublin, Ireland
4Medical Affairs, Janssen-Cilag Europe, 6341 Baar, Switzerland
5Global Medical Affairs, GMAL Mature Products, Johnson & Johnson Pharmaceutical Services, LLC, 6341 Baar, Switzerland

Received 8 December 2010; Accepted 19 April 2011

Academic Editor: Anna Maria Aloisi

Copyright © 2011 Jozef Vojtaššák et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Linked References

  1. F. Brennan and M. J. Cousins, “Pain relief as a human right,” Pain Clinical Updates, vol. 12, no. 5, 2004. View at Publisher · View at Google Scholar · View at Scopus
  2. C. Harstall and M. Ospina, “How prevalent is chronic pain?” Pain Clinical Updates, vol. 11, no. 2, 2003. View at Publisher · View at Google Scholar · View at Scopus
  3. H. Breivik, B. Collett, V. Ventafridda, R. Cohen, and D. Gallacher, “Survey of chronic pain in Europe: prevalence, impact on daily life, and treatment,” European Journal of Pain, vol. 10, no. 4, pp. 287–333, 2006. View at Publisher · View at Google Scholar · View at Scopus
  4. “Chronic Pain in America: Roadblocks to Relief, a study conducted by Roper Starch Worldwide for American Academy of Pain Medicine, American Pain Society and Janssen Pharmaceutica, 1999,” 2010, http://www.ampainsoc.org/links/roadblocks/.
  5. D. A. Grammas and N. E. Lane, “Osteoarthritis,” in Treatment of the Rheumatic Diseases, M. H. Weismann and M. E. Weinblatt, Eds., vol. 25, pp. 1–24, Saunders, Philadelphia, Pa, USA, 2005. View at Google Scholar
  6. J. S. Lawrence, J. M. Bremner, and F. Bier, “Osteoarthritis: prevalence in the population and relationship between symptoms and X-ray changes,” Annals of the Rheumatic Diseases, vol. 25, no. 1, pp. 1–24, 1966. View at Google Scholar · View at Scopus
  7. “National Centre of Health Statistic: prevalence of osteoarthritis in adults by age, sex, race, and geographic areas: United States, 1960–1962,” Vital and Health Statistics, no. 15, 1966.
  8. N. J. Manek and N. E. Lane, “Osteoarthritis: current concepts in diagnosis and management,” American Family Physician, vol. 61, no. 6, pp. 1795–1804, 2000. View at Google Scholar · View at Scopus
  9. R. C. Lawrence, D. T. Felson, C. G. Helmick et al., “Estimates of the prevalence of arthritis and other rheumatic conditions in the United States. Part II,” Arthritis and Rheumatism, vol. 58, no. 1, pp. 26–35, 2008. View at Publisher · View at Google Scholar · View at Scopus
  10. W. Zhang, R. W. Moskowitz, G. Nuki et al., “OARSI recommendations for the management of hip and knee osteoarthritis, Part II: OARSI evidence-based, expert consensus guidelines,” Osteoarthritis and Cartilage, vol. 16, no. 2, pp. 137–162, 2008. View at Publisher · View at Google Scholar · View at Scopus
  11. M. Noble, J. R. Treadwell, S. J. Tregear et al., “Long-term opioid management for chronic noncancer pain,” Cochrane Database of Systematic Reviews, no. 1, Article ID CD006605, 2010. View at Google Scholar · View at Scopus
  12. A. M. Trescot, S. E. Glaser, H. Hansen, R. Benyamin, S. Patel, and L. Manchikanti, “Effectiveness of opioids in the treatment of chronic non-cancer pain,” Pain Physician, vol. 11, no. 2, pp. S181–S200, 2008. View at Google Scholar · View at Scopus
  13. J. C. Ballantyne, “Opioid analgesia: perspective on right use and utility,” Pain Physician, vol. 10, no. 3, pp. 479–491, 2007. View at Google Scholar · View at Scopus
  14. A. D. Furlan, J. A. Sandoval, A. Mailis-Gagnon, and E. Tunks, “Opioids for chronic noncancer pain: a meta-analysis of effectiveness and side effects,” Canadian Medical Association Journal, vol. 174, no. 11, pp. 1589–1594, 2006. View at Publisher · View at Google Scholar · View at Scopus
  15. E. Kalso, J. E. Edwards, R. A. Moore, and H. J. McQuay, “Opioids in chronic non-cancer pain: systematic review of efficacy and safety,” Pain, vol. 112, no. 3, pp. 372–380, 2004. View at Publisher · View at Google Scholar · View at Scopus
  16. R. Chou, E. Clark, and M. Helfand, “Comparative efficacy and safety of long-acting oral opioids for chronic non-cancer pain: a systematic review,” Journal of Pain and Symptom Management, vol. 26, no. 5, pp. 1026–1048, 2003. View at Publisher · View at Google Scholar · View at Scopus
  17. J. C. Ballantyne and J. Mao, “Opioid Therapy for Chronic Pain,” New England Journal of Medicine, vol. 349, no. 20, pp. 1943–1953, 2003. View at Publisher · View at Google Scholar · View at Scopus
  18. E. McNicol, “Opioid side effects,” Pain Clinical Updates, vol. 15, no. 2, 2007. View at Publisher · View at Google Scholar · View at Scopus
  19. E. Nüesch, A. W. Rutjes, E. Husni, V. Welch, and P. Jüni, “Oral or transdermal opioids for osteoarthritis of the knee or hip,” Cochrane Database of Systematic Reviews, no. 4, Article ID CD003115, 2009. View at Google Scholar · View at Scopus
  20. R. D. Jovey, J. Ennis, J. Gardner-Nix et al., “Use of opioid analgesics for the treatment of chronic noncancer pain—a consensus statement and guidelines from the Canadian Pain Society, 2002,” Pain Research & Management, vol. 8, supplement A, pp. 3A–28A, 2003. View at Publisher · View at Google Scholar · View at Scopus
  21. E. Kalso, L. Allan, P. L. Dellemijn et al., “Recommendations for using opioids in chronic non-cancer pain,” European Journal of Pain, vol. 7, no. 5, pp. 381–386, 2003. View at Publisher · View at Google Scholar · View at Scopus
  22. AGS Panel on Persistent Pain in Older Persons, “The management of persistent pain in older persons,” Journal of the American Geriatrics Society, vol. 50, no. 6, pp. S205–S224, 2002. View at Google Scholar · View at Scopus
  23. A. H. Vallerand, “The use of long-acting opioids in chronic pain management,” Nursing Clinics of North America, vol. 38, no. 3, pp. 435–445, 2003. View at Publisher · View at Google Scholar · View at Scopus
  24. W. Koizumi, H. Toma, K. Watanabe et al., “Efficacy and tolerability of cancer pain management with controlled-release oxycodone tablets in opioid-naive cancer pain patients, starting with 5  mg tablets,” Japanese Journal of Clinical Oncology, vol. 34, no. 10, pp. 608–614, 2004. View at Publisher · View at Google Scholar · View at Scopus
  25. H. Pan, Z. Zhang, Y. Zhang et al., “Efficacy and tolerability of oxycodone hydrochloride controlled-release tablets in moderate to severe cancer pain,” Clinical Drug Investigation, vol. 27, no. 4, pp. 259–267, 2007. View at Publisher · View at Google Scholar · View at Scopus
  26. R. Rauck, T. Ma, R. Kerwin, and H. Ahdieh, “Titration with oxymorphone extended release to achieve effective long-term pain relief and improve tolerability in opioid-naive patients with moderate to severe pain,” Pain Medicine, vol. 9, no. 7, pp. 777–785, 2008. View at Publisher · View at Google Scholar · View at Scopus
  27. M. Hale, I. C. Tudor, S. Khanna, and J. Thipphawong, “Efficacy and tolerability of once-daily OROS® hydromorphone and twice-daily extended-release oxycodone in patients with chronic, moderate to severe osteoarthritis pain: results of a 6-week, randomized, open-label, noninferiority analysis,” Clinical Therapeutics, vol. 29, no. 5, pp. 874–888, 2007. View at Publisher · View at Google Scholar · View at Scopus
  28. JurnistaTM monograph, Janssen Cilag,” 2006.
  29. S. Gupta and G. Sathyan, “Providing Constant Analgesia with OROS Hydromorphone,” Journal of Pain and Symptom Management, vol. 33, no. 2S, pp. S19–S24, 2007. View at Publisher · View at Google Scholar · View at Scopus
  30. R. H. Dworkin, D. C. Turk, S. Peirce-Sandner et al., “Placebo and treatment group responses in postherpetic neuralgia vs. painful diabetic peripheral neuropathy clinical trials in the REPORT database,” Pain, vol. 150, no. 1, pp. 12–16, 2010. View at Publisher · View at Google Scholar · View at Scopus
  31. Data on file, ALZA Corporation, Mountainview, CA, USA.
  32. J. A. Turner, R. A. Deyo, J. D. Loeser, M. Von Korff, and W. E. Fordyce, “The importance of placebo effects in pain treatment and research,” Journal of the American Medical Association, vol. 271, no. 20, pp. 1609–1614, 1994. View at Publisher · View at Google Scholar · View at Scopus
  33. B. S. Oken, “Placebo effects: clinical aspects and neurobiology,” Brain, vol. 131, no. 11, pp. 2812–2823, 2008. View at Publisher · View at Google Scholar · View at Scopus
  34. D. K. White, J. J. Keysor, M. P. LaValley et al., “Clinically important improvement in function is common in people with or at high risk of knee OA: the MOST study,” Journal of Rheumatology, vol. 37, no. 6, pp. 1244–1251, 2010. View at Publisher · View at Google Scholar · View at Scopus
  35. R. Langford, F. McKenna, S. Ratcliffe, J. Vojtaššák, and U. Richarz, “Transdermal fentanyl for improvement of pain and functioning in osteoarthritis: a randomized, placebo-controlled trial,” Arthritis and Rheumatism, vol. 54, no. 6, pp. 1829–1837, 2006. View at Publisher · View at Google Scholar · View at Scopus
  36. W. Zhang, M. Doherty, N. Arden et al., “EULAR evidence based recommendations for the management of hip osteoarthritis: report of a task force of the EULAR Standing Committee for International Clinical Studies Including Therapeutics (ESCISIT),” Annals of the Rheumatic Diseases, vol. 64, no. 5, pp. 669–681, 2005. View at Publisher · View at Google Scholar · View at Scopus