A 13-week, Randomized, Double-Blind, Placebo-Controlled, Monotherapy Trial of Pregabalin (BID) in Patients With Fibromyalgia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 751
- 试验地点
- 1
- 主要终点
- Change from baseline in functioning (score created from the Short Form-36 [SF-36] Social and Physical Functioning, Fibromyalgia Impact Questionnaire [FIQ]-Total Score, and Sheehan Disability Scale [SDS] Total Score) at Termination Visit
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of pregabalin versus placebo for the symptomatic relief of pain associated with fibromyalgia. If this objective is met, then the second objective will be to evaluate the efficacy and safety of pregabalin versus placebo for the management of fibromyalgia (pain, patient global assessment, and functional status). Additionally, the study will evaluate the efficacy of pregabalin versus placebo to improve sleep, fatigue, and mood disturbance associated with fibromyalgia.
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
- •Patients who met the American College of Rheumatology (ACR) criteria for fibromyalgia (ie, widespread pain present for at least 3 months, and pain in at least 11 of 18 specific tender point sites)
- •Patients who completed at least 4 pain diaries within the last 7 days and the average pain score must have been ≥4, and had a score of ≥40 mm on the Visual Analogue Scale (VAS) of the SF-MPQ at screening (Visit 1) and randomization (Visit 2)
排除标准
- •Patients with other severe pain that may confound assessment or self-evaluation of the pain associated with fibromyalgia
- •Patients with any inflammatory muscle or rheumatologic disease other than fibromyalgia, active infections, or untreated endocrine disorders
- •Patients with severe depression
研究组 & 干预措施
A
干预措施: Pregabalin (Drug)
B
干预措施: Pregabalin (Drug)
C
干预措施: Pregabalin (Drug)
D
干预措施: Placebo (Drug)
结局指标
主要结局
Change from baseline in functioning (score created from the Short Form-36 [SF-36] Social and Physical Functioning, Fibromyalgia Impact Questionnaire [FIQ]-Total Score, and Sheehan Disability Scale [SDS] Total Score) at Termination Visit
时间窗: Baseline and Weeks 5, 9, and 13
Endpoint mean pain score derived from the subject's daily pain diary
时间窗: Endpoint
Patient Global Assessment (Patient Global Impression of Change) at Termination Visit
时间窗: Weeks 5 and 13
次要结局
- Change from baseline in FIQ scores at Weeks 5, 9, and 13(Baseline and Weeks 5, 9, and 13)
- Change from baseline in SDS scores at Weeks 5, 9, and 13(Baseline and Weeks 5, 9, and 13)
- Change from baseline in Medical Outcomes Study (MOS)-Sleep Scale scores at Weeks 5, 9, and 13(Baseline and Weeks 5, 9, and 13)
- Quality of Sleep Score from the Daily Sleep Diary(Daily)
- Change from baseline in Multidimensional Assessment of Fatigue (MAF) scores at Weeks 5, 9, and 13(Baseline and Weeks 5, 9, and 13)
- Change from baseline in Hospital Anxiety and Depression Scale (HADS) scores at Week 13(Baseline and Week 13)
- Change from baseline in Short Form McGill Pain Questionnaire (SF-MPQ) scores at Weeks 5, 9, and 13(Screening, baseline, and Weeks 5, 9, and 13)
- Change from baseline in Fibromyalgia Health Assessment Questionnaire (F-HAQ) scores at Weeks 9 and 13(Baseline and Weeks 9 and 13)
- Adverse events(Weeks 1, 2, 5, 9, 13, and at follow-up)
- Physical examination, including vital signs and weight(Baseline and Week 5 (vital signs only) and 13)
- Neurological examination(Screening and Week 13)
- Electrocardiogram(Screening and Week 13)
- Laboratory tests, including chemistry and hematology(Baseline and Weeks 5, 13, and at follow-up)
- Urinalysis(Baseline and Weeks 13 and at follow-up)