DULOXETINE TREATMENT FOR ACTIVITY-LIMITING OSTEOARTHRITIS PAIN

度洛西汀治疗限制活动的骨关节炎疼痛

• 批准号: 7603499
• 负责人: MARK A SULLIVAN
• 金额: $ 0.61万
• 依托单位: UNIVERSITY OF WASHINGTON
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-04-01 至 2007-09-16
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7603499
• 关键词: Acetaminophen; Aftercare; Antidepressive Agents; Computer Retrieval of Information on Scientific Projects Database; Degenerative polyarthritis; Dose; Funding; Grant; Institution; Label; Mental Depression; Non-Steroidal Anti-Inflammatory Agents; Outcome Assessment; Pain; Placebos; Randomized Controlled Clinical Trials; Research; Research Design; Research Personnel; Resources; Severities; Source; United States National Institutes of Health; Week; day; depressive symptoms; design; duloxetine; improved; randomized placebo controlled trial; week trial

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Study Hypothesis: In subjects who continue to have activity-limiting osteoarthritis pain after treatment with acetaminophen or non-steroidal anti-inflammatory agents, 60-90 mg Duloxetine per day will provide significant additional pain relief (> 30%) Study Design: This will be a single-blind, placebo washout trial. This is more rigorous than an open label design, but easier to accomplish than a randomized placebo-controlled trial. It is appropriate because there are no trials (randomized or open) of antidepressants for OA pain. Subjects will be informed that they may receive placebo during the course of the trial, but they will not know that all subjects will receive placebo for the first 2 weeks of the trial. Following 2 weeks of placebo, non-responders will be advanced over a 4-6 week period to 60 or 90 mg of duloxetine per day as tolerated. They will be maintained on this dose for 6 weeks. Primary outcome assessment will occur after 12 weeks of duloxetine treatment. Anticipated Findings: We anticipate a >30% pre-treatment to post-treatment difference in average pain intensity independent of initial depression severity. Depressive symptoms will also improve but pain effects will be demonstrated to be independent by path analysis.

该副本是利用众多研究子项目之一 由NIH/NCRR资助的中心赠款提供的资源。子弹和 调查员（PI）可能已经从其他NIH来源获得了主要资金， 因此可以在其他清晰的条目中代表。列出的机构是 对于中心，这不一定是调查员的机构。 研究假设： 在用对乙酰氨基酚或非甾体类抗炎药治疗后继续患有限制活性骨关节炎的受试者中，每天60-90 mg杜洛西汀将提供明显的额外疼痛缓解（> 30％） 研究设计： 这将是一项单盲安慰剂清洗试验。这比开放标签设计更严格，但比随机安慰剂对照试验更容易完成。这是适当的，因为没有针对OA疼痛的抗抑郁药的试验（随机或开放）。 受试者将被告知他们在审判过程中可能会接受安慰剂，但他们不会知道所有受试者将在审判的前2周接受安慰剂。安慰剂2周后，在4-6周期间，非反应者将在每天的4-6周期间提高到60或90毫克的杜洛西汀。它们将在此剂量上维持6周。杜洛西汀治疗12周后，将进行主要结果评估。 预期的发现： 我们预计，在平均疼痛强度的平均疼痛强度差异> 30％的治疗中，与初始抑郁严重程度无关。抑郁症状也会改善，但通过路径分析证明疼痛影响将独立。