临床试验/NCT01276431

NCT01276431已完成4 期

Norspan Efficacy and Safety Among Elderly Subjects

Mundipharma AB2 个研究点分布在 1 个国家目标入组 102 人开始时间: 2011年3月最近更新: 2014年2月6日

适应症

干预措施

试验速览

阶段: 4 期
状态: 已完成
发起方: Mundipharma AB
入组人数: 102
试验地点: 2
主要终点: Box Scale-11 (BS-11) pain scores (pain on average during the last seven days, mean change from Baseline to Completion (fulfilled all visits in the study).

研究概览研究设计入排标准研究组 & 干预措施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

An open label, multi-centre, prospective age-group-controlled study to evaluate efficacy and safety of buprenorphine transdermal patches in subjects with chronic, moderate to severe osteoarthritis pain of the hip and/or knee.

研究设计

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

入排标准

年龄范围: 50 Years 至 75 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

未提供

排除标准

未提供

研究组 & 干预措施

Buprenorphine transdermal patch

Other

For two age groups: 50-60 years and >= 75 years of age

干预措施: Buprenorphine transdermal patch (Drug)

结局指标

主要结局

Box Scale-11 (BS-11) pain scores (pain on average during the last seven days, mean change from Baseline to Completion (fulfilled all visits in the study).

次要结局

Western Ontario & McMaster Universities OA Index
European QOL Health Questionnaire
Sleep disturbance & quality of sleep questions
Patients global assessment of pain relief
Investigators global assessment of pain relief
Incidence of rescue medication

研究者

发起方

Mundipharma AB

申办方类型

Industry

责任方

Sponsor

研究点 (2)

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