NCT01387607已完成3 期
A 14-week, Randomized, Double-blind Placebo-controlled Study For Pregabalin In Subjects With Fibromyalgia
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.22 个研究点 分布在 1 个国家目标入组 343 人开始时间: 2012年2月6日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 343
- 试验地点
- 22
- 主要终点
- Change From Baseline in Endpoint Mean Pain Score During the Double-blind Treatment Period at Week 14
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and tolerability of pregabalin compared with placebo for management of fibromyalgia in adults.
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
- Double (Participant, Investigator)
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
- •Male or female patients, at least 18 years of age
- •Meeting the ACR (America College of Rheumatology) criteria for fibromyalgia (ie, widespread pain present for at least 3 months, and pain in at least 11 of 18 specific tender point sites)
- •At screening (V1) and randomization (V2), patients must have a score of no less than 40 mm on the Pain Visual Analog Scale (VAS)
- •At randomization (V2), at least 4 pain diaries must be completed satisfactorily within the last 7 days and the average pain score must be no less than 4
排除标准
- •Patients with no less than 30% decrease on the Pain Visual Analog Scale (VAS) at randomization (V2) as compared to screening (V1)
- •Patients with other severe pain due to other conditions (eg, DPN or PHN) that may confound assessment or self-evaluation of the pain associated with fibromyalgia
- •Patients with any widespread inflammatory musculoskeletal disorders, widespread rheumatic diseases other than fibromyalgia, active infections, or untreated endocrine disorders
- •CLcr less than 60 mL/min (estimated from serum creatinine)
研究组 & 干预措施
Pregabalin
Experimental
干预措施: pregabalin (Drug)
Placebo
Placebo Comparator
Matched placebo
干预措施: placebo (Drug)
结局指标
主要结局
Change From Baseline in Endpoint Mean Pain Score During the Double-blind Treatment Period at Week 14
时间窗: Baseline, Week 14
Assessment of mean pain score was based on participant's daily pain diary. The daily pain diary consisted of an 11-point numeric rating scale ranging from 0 (no pain) to 10 (worst possible pain). The participants rated their pain during the past 24 hours by choosing the appropriate number between 0 and 10. Self-assessment was performed daily at awakening. The endpoint mean pain score was defined as the mean of the Week 14 pain diary entries in the double-blind treatment phase. Baseline was defined as the mean of last 7 pain diary entries up to and including Day 1.
次要结局
- Change From Baseline at Week 14 in Medical Outcome Study (MOS)-Sleep Scale - Sleep Disturbance Subscale Score(Baseline, Week 14)
- Change From Baseline at Week 14 in Subjective Sleep Questionnaire (SSQ) - Subjective Total Sleep Time (sTST)(Baseline, Week 14)
- Percentage of Participants Categorized by Each Patient Global Impression of Change (PGIC) Score at Week 14(Week 14)
- Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) Total Score at Week 14(Baseline, Week 14)
- Percentage of Participants With at Least 30% Reduction in Weekly Mean Pain Score From Baseline to Week 14(Baseline, Week 14)
- Percentage of Participants With at Least 50% Reduction in Weekly Mean Pain Score From Baseline to Week 14(Baseline, Week 14)
- Change From Baseline at Week 14 in Medical Outcome Study (MOS)-Sleep Scale - Snoring, Awaken Short of Breath and Sleep Adequacy Subscale Scores(Baseline, Week 14)
- Change From Baseline at Week 14 in Medical Outcome Study (MOS)-Sleep Scale - Sleep Problems Index Overall Score(Baseline, Week 14)
- Percentage of Participants With Optimal Sleep at Week 14 in Medical Outcome Study (MOS)-Sleep Scale(Baseline, Week 14)
- Change From Baseline at Week 14 in Medical Outcome Study (MOS)-Sleep Scale - Quantity of Sleep and Somnolence Subscale Scores(Baseline, Week 14)
- Change From Baseline in Mean Sleep Interference Score at Week 14(Baseline, Week 14)
- Change From Baseline at Week 14 in Subjective Sleep Questionnaire (SSQ) - Subjective Wake After Sleep Onset (sWASO)(Baseline, Week 14)
- Change From Baseline at Week 14 in Subjective Sleep Questionnaire (SSQ) - Subjective Latency to Sleep Onset (sLSO)(Baseline, Week 14)
- Change From Baseline at Week 14 in Subjective Sleep Questionnaire (SSQ) - Subjective Number of Awakenings After Sleep Onset (sNAASO)(Baseline, Week 14)
- Change From Baseline at Week 14 in Subjective Sleep Questionnaire (SSQ) - Sleep Quality(Baseline, Week 14)
- Change From Baseline at Week 14 in Short-Form 36 (SF-36) Health Survey - Mental Component Summary Score(Baseline, Week 14)
- Change From Baseline in Multidimensional Assessment of Fatigue (MAF) Score at Week 14(Baseline, Week 14)
- Change From Baseline at Week 14 in Short-Form 36 (SF-36) Health Survey - Physical Component Summary Score(Baseline, Week 14)
- Change From Baseline in Pain Visual Analog Scale (Pain VAS) Score at Week 14(Baseline, Week 14)
- Change From Baseline at Week 14 in Hospital Anxiety and Depression Scale (HADS) - Depression Subscale Score(Baseline, Week 14)
- Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Discontinuation Due to AEs(Baseline to Follow up (Day 105))
- Change From Baseline at Week 14 in Hospital Anxiety and Depression Scale (HADS) - Anxiety Subscale Score(Baseline, Week 14)
- Number of Treatment-Emergent Adverse Events (TEAEs) Categorized by Severity(Baseline to Follow up (Day 105))
研究者
研究点 (22)
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