A Randomised Open Controlled Parallel Group Multicenter Study to Evaluate the Efficacy and Safety of Norspan Versus Tiparol Retard in Subjects With Chronic Moderate to Severe OA Pain of the Hip and/or Knee.

Mundipharma AB2 个研究点分布在 1 个国家目标入组 160 人开始时间: 2006年11月最近更新: 2007年8月17日

适应症

试验速览

阶段: 4 期
状态: 已完成
发起方: Mundipharma AB
入组人数: 160
试验地点: 2
主要终点: Box Scale 11 pain scores for pain on average during the last week then mean change from base line to completion. BS11 is recorded daily by the patients in a diary.

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

To evaluate the efficacy and safety of Norspan versus Tiperol Retard among OA patients who are sub-optimally treated with current analgesic. Those patients may benefit from treatment with a long lasting analgesic.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: None

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•OA diagnosis
•BS11 greater than or equal to 4 at base line
•Not adequately pain relieved with 4,000 mg paracetamol daily

排除标准

•Treated with high potent opioids for their OA pain
•Treated with a regular dose for greater than one week of Tramadol, Codeine or dextropropoxifene during the last three months
•Other chronic conditions requiring frequent analgesic therapy

结局指标

主要结局

Box Scale 11 pain scores for pain on average during the last week then mean change from base line to completion. BS11 is recorded daily by the patients in a diary.

次要结局

Rescue medication recorded daily by patients. Sleep disturbance and quality of sleep. Patients global assessment of pain relief, investigators global assessment of pain relief, patients preference, WOMAC OA index, EuroQoL EQ-5D.

研究者

发起方

Mundipharma AB

申办方类型

Industry

研究点 (2)

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