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
المؤلفون المشاركون
Vojtaššák, Jozef
Jacobs, Adam
Vojtaššák, Jozef
Richarz, Ute
Waechter, Sandra
Rynn, Leonie
المصدر
العدد
المجلد 2011، العدد 2011 (31 ديسمبر/كانون الأول 2011)، ص ص. 1-9، 9ص.
الناشر
Hindawi Publishing Corporation
تاريخ النشر
2011-06-22
دولة النشر
مصر
عدد الصفحات
9
التخصصات الرئيسية
الملخص 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.
نمط استشهاد جمعية علماء النفس الأمريكية (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
نمط استشهاد الجمعية الأمريكية للغات الحديثة (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
نمط استشهاد الجمعية الطبية الأمريكية (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
نوع البيانات
مقالات
لغة النص
الإنجليزية
الملاحظات
Includes bibliographical references
رقم السجل
BIM-456465
قاعدة معامل التأثير والاستشهادات المرجعية العربي "ارسيف Arcif"
أضخم قاعدة بيانات عربية للاستشهادات المرجعية للمجلات العلمية المحكمة الصادرة في العالم العربي
تقوم هذه الخدمة بالتحقق من التشابه أو الانتحال في الأبحاث والمقالات العلمية والأطروحات الجامعية والكتب والأبحاث باللغة العربية، وتحديد درجة التشابه أو أصالة الأعمال البحثية وحماية ملكيتها الفكرية. تعرف اكثر