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Pain Research and Treatment
Volume 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.

Abstract

Background. Opioid analgesics are included in treatment guidelines for the symptomatic management of osteoarthritis (OA). Starting with a low dose of opioid and slowly titrating to a higher dose may help avoid intolerable side effects. Methods. Subjects aged ≥40 years, with moderate to severe pain induced by OA of the hip or knee not adequately controlled by previous non-steroidal anti-inflammatory drugs (NSAIDs) or paracetamol treatment, were enrolled. Subjects received OROS hydromorphone 4 mg or placebo once-daily. The dose was titrated every 3-4 days in case of unsatisfactory pain control during the 4-week titration phase. A 12 week maintenance phase followed. The primary efficacy endpoint was the change in “pain on average” measured on the Brief Pain Inventory (BPI) scale from baseline to the end of the maintenance phase. Results. 139 subjects received OROS hydromorphone and 149 subjects received placebo. All efficacy endpoints showed similar improvements from baseline to end of study in the 2 groups. The safety results were consistent with the safety profile of OROS hydromorphone. Conclusion.The study did not meet the primary endpoint; although many subjects' pain was not adequately controlled at inclusion, their pain may have improved with continued paracetamol or NSAID treatment.