RCT of Duloxetine & Pregabalin for the treatment of Gulf War Illness in Veterans

度洛西汀的 RCT

• 批准号: 9336825
• 负责人: Dena Davidson
• 金额: --
• 依托单位: OLIN TEAGUE VETERANS CENTER
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-04-01 至 2019-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9336825
• 关键词: Adrenal Glands; Adverse effects; Biogenic Amines; Brain; Calcium Channel; Cerebrospinal Fluid; Chronic; Classification Scheme; Combined Modality Therapy; Complex; Data; Development; Dose; Double-Blind Method; FDA approved; Fatigue; Fibromyalgia; Genes; Genetic; Gulf War; Headache; Home environment; Hypothalamic structure; Immune response; Individual; Kansas; Ligands; Measures; Mediator of activation protein; Memory; Mono-S; Moods; Nerve Growth Factors; Neurotransmitters; Norepinephrine; Outcome; Pain; Pain Attribute; Pain management; Participant; Pharmaceutical Preparations; Phase; Physical Function; Pituitary Gland; Placebos; Randomized; Randomized Clinical Trials; Randomized Controlled Clinical Trials; Randomized Controlled Trials; Regulation; Research; Safety; Serotonin; Sleep; Sleep disturbances; Statistical Data Interpretation; Structure; Substance P; Symptoms; Testing; Texas; Therapeutic; Veterans; active method; arm; associated symptom; central pain; chronic widespread pain; clinical practice; clinically relevant; control trial; dosage; duloxetine; effective therapy; experience; gastrointestinal; impression; improved; inhibitor/antagonist; open label; pregabalin; public health relevance; response; reuptake; symptomatic improvement; treatment group

DESCRIPTION (provided by applicant): The proposed randomized controlled clinical trial is a resubmission to the CSR&D RFA on new treatments for Gulf War illnesses. In a randomized, double-blind, controlled trial, 180 Veterans who meet defining criteria for GWI and whose symptom profile includes chronic widespread pain and fatigue will be treated for 18 weeks with one of the following combinations; Group 1) AM Duloxetine + PM placebo; Group 2) AM placebo and PM Pregabalin; or Group 3) AM placebo + PM placebo. PRIMARY AIM 1: To evaluate the efficacy of a Duloxetine and Pregabalin for the treatment of pain and safety and tolerability of the medications in Veterans with GWI. It is anticipated that monotherapy with Duloxetine or Pregabalin will result in a greater number of GWI participants achieving a clinically relevant reduction in pain compared to PBO alone. SECONDARY AIM 2: To evaluate the efficacy of a Duloxetine and Pregabalin for the treatment of sleep, fatigue, and mood in Veterans with GWI. It is anticipated that the active treatments in Group 1 & 2 will result in numerically greater improvement in these symptoms compared to Group 3. EXPLORATORY GENETIC AIM: To obtain pilot data on genes associated with medication response and to begin development of potential classification schemes that could guide choice of therapy.

描述（由申请人提供）： 拟议的随机对照临床试验是对海湾战争疾病新治疗的CSR＆d RFA的重新提交。在一项随机，双盲，对照试验中，有180名退伍军人符合GWI定义标准，其症状特征包括慢性广泛疼痛和疲劳，将通过以下组合之一进行18周的治疗。第1组）AM Duloxetine + PM安慰剂；第2组）AM安慰剂和PM Pregabalin；或第3组）AM安慰剂 + PM安慰剂。主要目的1：评估Duloxetine和Pregabalin对GWI退伍军人的疼痛和安全性以及药物耐受性的疗效。预计用杜洛西汀或果岭单一疗法会导致更大的 与单独的PBO相比，GWI参与者的疼痛减轻临床相关。次要目的2：评估Duloxetine和Pregabalin对GWI退伍军人的睡眠，疲劳和情绪的疗效。预计与第3组相比，第1和2组中的主动治疗将在数值上改善这些症状。探索性遗传目的：获取与药物反应相关的基因的试验数据，并开始开发可以指导治疗选择的潜在分类方案。