NCT01271933已完成3 期
A Phase 3 Double-blind, Randomized, Placebo-controlled, Safety And Efficacy Study Of Once Daily Controlled Release Pregabalin In The Treatment Of Patients With Fibromyalgia (Protocol A0081245)
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.52 个研究点 分布在 4 个国家目标入组 441 人开始时间: 2011年3月最近更新:
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
- 441
- 试验地点
- 52
- 主要终点
- Double-Blind Phase: Number of Participants With Loss of Therapeutic Response (LTR) Event
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of a controlled release formulation of pregabalin administered once daily as compared to placebo in the treatment of fibromyalgia. All patients will receive pregabalin; half of the patients will receive placebo at some point in the study.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 must have fibromyalgia.
排除标准
- •Patients with other painful conditions cannot participate.
研究组 & 干预措施
Pregabalin
Experimental
干预措施: pregabalin (Drug)
Placebo
Placebo Comparator
干预措施: placebo (Drug)
结局指标
主要结局
Double-Blind Phase: Number of Participants With Loss of Therapeutic Response (LTR) Event
时间窗: Randomization to Week 19
Participants who did not maintain at least 30% pain response during the DB phase relative to baseline or were discontinued during DB due to lack of efficacy or an adverse event were considered to have a loss of therapeutic response.
Double-Blind Phase: Time to Loss of Therapeutic Response (LTR)
时间窗: Randomization to Week 19
The time to loss of therapeutic response (LTR) is the time to loss of pain response (\<30% pain response relative to the single-blind (SB) baseline mean pain) or withdrawal due to lack of efficacy or adverse events (in the double blind phase).
次要结局
- Double-Blind Phase: Change From Baseline in Average Daily Tiredness Score at Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20(Baseline, Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20)
- Double-Blind Phase: Change From Baseline in Mean Daily Pain Score at Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20(Baseline, Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20)
- Double-Blind Phase: Change From Baseline in Mean Daily Pain Score at Double Blind Endpoint Visit(Baseline, Double blind endpoint visit (Week 19))
- Double-Blind Phase: Change From Baseline in Average Daily Tiredness Score at Double Blind Endpoint Visit(Baseline, Double blind endpoint visit (Week 19))
- Single-Blind Phase: Change From Baseline in Mean Daily Pain Score at Weeks 1, 2, 3, 4, 5, 6(Baseline, Weeks 1, 2, 3, 4, 5, 6)
- Single-Blind Phase: Change From Baseline in Average Daily Tiredness Score at Weeks 1, 2, 3, 4, 5, 6(Baseline, Weeks 1, 2, 3, 4, 5, 6)
- Single-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Subjective Wake After Sleep and Subjective Latency to Sleep Onset at Weeks 1, 2, 3, 4, 5, 6(Baseline, Weeks 1, 2, 3, 4, 5, 6)
- Single-Blind Phase: Change From Baseline in Daily SSQ - Subjective Number of Awakenings After Sleep Onset at Weeks 1, 2, 3, 4, 5, 6(Baseline, Weeks 1, 2, 3, 4, 5, 6)
- Double-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Sleep Quality at Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20(Baseline, Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20)
- Double-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Subjective Wake After Sleep Onset and Subjective Latency to Sleep Onset at Double Blind Endpoint Visit(Baseline, Double blind endpoint visit (Week 19))
- Double-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Subjective Number of Awakenings After Sleep Onset at Double Blind Endpoint Visit(Baseline, Double blind endpoint visit (Week 19))
- Double-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Subjective Total Sleep Time at Double Blind Endpoint Visit(Baseline, Double blind endpoint visit (Week 19))
- Single-Blind Phase: Change From Baseline in Daily SSQ - Subjective Total Sleep Time at Weeks 1, 2, 3, 4, 5, 6(Baseline, Weeks 1, 2, 3, 4, 5, 6)
- Single-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Sleep Quality at Weeks 1, 2, 3, 4, 5, 6(Baseline, Weeks 1, 2, 3, 4, 5, 6)
- Double-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Subjective Wake After Sleep Onset and Subjective Latency to Sleep Onset at Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20(Baseline, Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20)
- Double-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Subjective Number of Awakenings After Sleep Onset at Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20(Baseline, Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20)
- Double-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Subjective Total Sleep Time at Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20(Baseline, Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20)
- Change From Baseline in Medical Outcomes Study-Sleep Scale (MOS-SS) at Week 6 - Sleep Disturbance, Snoring, Awakening Short of Breath or With a Headache, Sleep Adequacy, Somnolence, Sleep Problems Index I and Sleep Problems Index II(Baseline, Week 6)
- Double-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Sleep Quality at Double Blind Endpoint Visit(Baseline, Double blind endpoint visit (Week 19))
- Single-Blind Phase: Change From Baseline in Weekly Pain Score at Week 6 (1 Week Recall Period)(Baseline, Week 6)
- Double-Blind Phase: Change From Baseline in Weekly Pain Score at Week 19 (1 Week Recall Period)(Baseline, Week 19)
- Change From Baseline in Medical Outcomes Study-Sleep Scale (MOS-SS) at Week 6- Quantity of Sleep(Baseline, Week 6)
- Double-Blind Phase: Change From Baseline in Medical Outcomes Study-Sleep Scale (MOS-SS) at Week 19-Sleep Disturbance, Snoring, Awakening Short of Breath or With a Headache, Sleep Adequacy, Somnolence, Sleep Problems Index I and Sleep Problems Index II(Baseline, Week 19)
- Double-Blind Phase: Change From Baseline in Medical Outcomes Study-Sleep Scale (MOS-SS) at Week 19- Quantity of Sleep(Baseline, Week 19)
- Single-Blind Phase: Number of Participants Who Reported Global Impression of Change (PGIC) at Week 6(Week 6)
- Double-Blind Phase: Number of Participants Who Reported Global Impression of Change (PGIC) at Week 19(Week 19)
- Single-Blind Phase: Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 6(Baseline, Week 6)
- Single-Blind Phase: Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Week 6(Baseline, Week 6)
- Double-Blind Phase: Change From Baseline in SF-36 Score at Week 19(Baseline, Week 19)
- Single-Blind Phase: Change From Baseline in Hospital Anxiety and Depression Scale (HADS) at Week 6(Baseline, Week 6)
- Double-Blind Phase: Change From Baseline in HADS Score at Week 19(Baseline, Week 19)
- Double-Blind Phase: Change From Baseline in FIQ Score at Week 19(Baseline, Week 19)
- Single-Blind Phase: Change From Baseline in Multidimensional Fatigue Inventory (MFI) at Week 6(Baseline, Week 6)
- Double-Blind Phase: Change From Baseline in MFI Score at Week 19(Baseline, Week 19)
- Single-Blind Phase: Number of Participants With Benefit, Satisfaction, Willingness to Continue Measure (BSW) at Week 6(Week 6)
- Double-Blind Phase: Number of Participants With Benefit, Satisfaction, and Willingness (BSW) to Continue Data at Visit 9 (3 Component Questions) at Week 19(Week 19)
- Single-Blind Phase: Change From Baseline in Work Productivity and Activity Impairment (WPAI) Questionnaire at Week 6(Baseline, Week 6)
- Double-Blind Phase: Change From Baseline WPAI Questionnaire at Week 19(Baseline, Week 19)
- Double-Blind Phase: Change From Baseline in Actigraphy Functional/Sleep Assessment - Total Daytime Activity at Double Blind End Point Visit (Week 19)(Baseline, Double blind end point visit (Week 19))
研究者
研究点 (52)
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