NCT01693692已完成2 期
A Phase 2 Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study of TD-9855 in Patients With Fibromyalgia (FM)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 392
- 试验地点
- 32
- 主要终点
- Percentage Change in Pain Score Based on the Mean of the Last 7 Daily Pain Numeric Rating Scale (NRS) Scores From the Daily Pain Diaries
研究概览
简要总结
The purpose of this study study is to determine whether TD-9855 is effective in treating patients 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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• American College of Rheumatology (ACR) Diagnostic Criteria for Fibromyalgia (FM)
- •Informed consent
- •18 to 65 years of age
- •Discontinue therapy with adrenergic-acting drugs, and certain other medications
- •Only acetaminophen or NSAID as rescue pain medication
- •No narcotic pain meds or benzodiazepines
- •Only non-benzodiazepines as rescue hypnotics
排除标准
- •Any current psychiatric disorder, lifetime bipolar disorder, severe comorbid Axis II disorder, mental retardation, etc, as assessed by Mini International Neuropsychiatric Interview (MINI)
- •Major depression at screening by MINI when unable to be washed out of MDD meds (investigator or provider's judgment)
- •Risk of suicide (investigator opinion and/or C-SSRS)
- •Recent history of substance or alcohol abuse
- •BMI <18 or ≥45
- •Concurrent disease; pain for diagnosed illness other than FM; non-compliance; history of seizures; pheochromocytoma; glaucoma; CV disease; orthostatic hypotension or orthostatic tachycardia; untreated sleep apnea
- •Abnormal lab values (liver, kidney, thyroid, and others)
研究组 & 干预措施
TD-9855 Group 1
Experimental
Group 1 to be dosed with TD-9855
干预措施: TD-9855 Group 1 (Drug)
TD-9855 Group 2
Experimental
Group 2 to be dosed with TD-9855
干预措施: TD-9855 Group 2 (Drug)
Placebo
Placebo Comparator
Group to be dosed with Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage Change in Pain Score Based on the Mean of the Last 7 Daily Pain Numeric Rating Scale (NRS) Scores From the Daily Pain Diaries
时间窗: Baseline and Week 6
Pain NRS score is based on an 11-point scale where 0 represents no pain and 10 represents the worst possible pain.
次要结局
- Fibromyalgia Impact Questionnaire (FIQ)(Day 43 (End of study treatment))
- Patient Global Impression of Change (PGIC)(Day 43 (End of study treatment))
研究者
研究点 (32)
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