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. 2011:2011:239501.
doi: 10.1155/2011/239501. Epub 2011 Jun 22.

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

Jozef Vojtaššák  1 , Jozef Vojtaššák, Adam Jacobs, Leonie Rynn, Sandra Waechter, Ute Richarz
Affiliations

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

Jozef Vojtaššák et al. Pain Res Treat. 2011.

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.

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Figures

Figure 1
Figure 1
Flow of participants through the study.
Figure 2
Figure 2
Mean change from baseline in BPI item 5 (pain on average) score by time (ITT population). Endpoint includes final assessments for subjects who discontinued before the end of the study.
Figure 3
Figure 3
Mean BPI score item 5 (pain on average) by concomitant NSAID use and treatment (ITT population).
See this image and copyright information in PMC

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