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
Joint Authors
Vojtaššák, Jozef
Jacobs, Adam
Vojtaššák, Jozef
Richarz, Ute
Waechter, Sandra
Rynn, Leonie
Source
Issue
Vol. 2011, Issue 2011 (31 Dec. 2011), pp.1-9, 9 p.
Publisher
Hindawi Publishing Corporation
Publication Date
2011-06-22
Country of Publication
Egypt
No. of Pages
9
Main Subjects
Abstract EN
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.
American Psychological Association (APA)
Vojtaššák, Jozef& Vojtaššák, Jozef& Jacobs, Adam& Rynn, Leonie& Waechter, Sandra& Richarz, Ute. 2011. 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. Pain Research and Treatment،Vol. 2011, no. 2011, pp.1-9.
https://search.emarefa.net/detail/BIM-456465
Modern Language Association (MLA)
Vojtaššák, Jozef…[et al.]. 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. Pain Research and Treatment No. 2011 (2011), pp.1-9.
https://search.emarefa.net/detail/BIM-456465
American Medical Association (AMA)
Vojtaššák, Jozef& Vojtaššák, Jozef& Jacobs, Adam& Rynn, Leonie& Waechter, Sandra& Richarz, Ute. 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. Pain Research and Treatment. 2011. Vol. 2011, no. 2011, pp.1-9.
https://search.emarefa.net/detail/BIM-456465
Data Type
Journal Articles
Language
English
Notes
Includes bibliographical references
Record ID
BIM-456465