NCT00151489已完成3 期
A Six-Month, Double-Blind, Placebo Controlled, Durability of Effect Study of Pregabalin for Pain Associated With Fibromyalgia
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.110 个研究点 分布在 1 个国家目标入组 1,020 人开始时间: 2005年4月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,020
- 试验地点
- 110
- 主要终点
- To evaluate the efficacy of pregabalin (BID) compared with placebo in assessing the durability of effect for the treatment of pain associated with fibromyalgia among patients who initially respond to open-label pregabalin using Pain Visual Analog Scale
研究概览
简要总结
The purpose of this research study of pregabalin and fibromyalgia is to see if 1. pregabalin reduces the pain of fibromyalgia and if this effect lasts for six months and 2. to see if different dosages work better (reduce pain and mild to no side effects) for different people.
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
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
- •At screening (V1), patients must meet the American College of Rheumatology criteria for fibromyalgia (i.e. widespread pain present for at least 3 months, and pain in at least 11 of 18 specific tender point sites
- •At Screen (V1) and enrollment (V2), patients must have a score of greater than 40 mm on the Pain Visual Analog Scale
排除标准
- •Other severe pain or inflammatory muscle or rheumatologic disease other than fibromyalgia, active infections or untreated endocrine disorders; or severe depression and other serious hepatic, respiratory, hematologic or immunologic illness or active malignancy or history of malignancy (examples of prohibited diseases: Hepatitis C, HIV, diabetes with nerve pain, other nerve pain (shingles), sleep apnea, epilepsy, narcolepsy, rheumatoid arthritis, generalized osteoarthritis, Lupus, Lyme disease unless sign and symptom free for 2 years, Sjogren's Syndrome, Sarcoid, Psoriatic Arthritis, Scleroderma)
- •Previous participation in a clinical trial with pregabalin; currently receiving or pending disability claims or workmans compensation or civil litigation, or used other experimental medicines within 30 days of screening
- •Creatinine Clearance less than 60 mL/min (estimated from serum creatinine; low platelet and/or white blood cell counts; abnormal Westergren erythrocyte sedimentation rate; abnormal antinuclear antibody (ANA greater than 3U), or rheumatoid factor (RF greater than 80 IU/mL); abnormal (clinically relevant 12 lead ECG)
- •Use of prohibited pain/sleep medications (including antidepressants, sedatives, hypnotics, NSAIDs, opiates, muscle relaxants) during the study. Washout required prior to study entry.
结局指标
主要结局
To evaluate the efficacy of pregabalin (BID) compared with placebo in assessing the durability of effect for the treatment of pain associated with fibromyalgia among patients who initially respond to open-label pregabalin using Pain Visual Analog Scale
次要结局
- To evaluate the efficacy of pregabalin (BID) compared with placebo treatment to relieve pain and to improve global assessment, functional status, sleep and fatigue associated with fibromyalgia using questionnaires. To evaluate the longterm safety
研究者
研究点 (110)
Loading locations...
相似试验
已完成
1 期
An fMRI Study Of Brain Response In Patients With FibromyalgiaFibromyalgiaNCT00760474Pfizer's Upjohn has merged with Mylan to form Viatris Inc.27
撤回
4 期
Fibromyalgia of Less Than One Year Duration. Study of PregabalinFibromyalgiaNCT01397006Newton-Wellesley Hospital
终止
3 期
Pregabalin Versus Placebo In The Treatment Of Neuropathic Pain Associated With HIV NeuropathyNeuropathyNCT01049217Pfizer's Upjohn has merged with Mylan to form Viatris Inc.377
已完成
4 期
Pregabalin in the Treatment of Pain Due to Diabetic Peripheral NeuropathyDiabetic Neuropathy, PainfulNCT00159679Pfizer's Upjohn has merged with Mylan to form Viatris Inc.167
已完成
3 期
A 17-Week Trial To Assess Pregabalin For The Treatment Of Nerve Pain Due To Spinal Cord InjuryNeuralgiaSpinal Cord InjuriesNCT00407745Pfizer's Upjohn has merged with Mylan to form Viatris Inc.220