A Phase 3b Multicenter, Double-blind, Randomized, Placebo-controlled, 2-way Crossover Study Of Pregabalin In The Treatment Of Fibromyalgia With Concurrent Antidepressant Therapy For Comorbid Depression (Protocol A0081275)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 197
- 试验地点
- 37
- 主要终点
- Mean NRS Pain Score at End of Period.
研究概览
简要总结
The intent of this study is to identify and treat fibromyalgia subjects with comorbid depression who are receiving an SSRI (selective serotonin reuptake inhibitor) or SNRI (selective norepinephrine reuptake inhibitor) primarily for their depression and to determine whether pregabalin demonstrates improvement relative to placebo in improving pain associated with fibromyalgia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •Men or women of any race or ethnicity who are at least 18 years of age.
- •Adult women and men with a diagnosis of fibromyalgia and stable depression (major depressive disorder, depression not otherwise specified (NOS), or dysthymia) who have been taking an antidepressant (SSRI or SNRI) primarily for their depression for at least 3 months.
排除标准
- •Have failed pregabalin treatment due to lack of improvement of symptoms at doses of greater than or equal to 300 mg daily, cannot tolerate pregabalin or any pregabalin ingredient, or participated in a pregabalin clinical trial. If the subject has taken pregabalin and discontinued for reason other than lack of improvement or intolerance, then they will be eligible. Pregabalin use within the last 30 days (prior to V1) is not permitted.
- •Patients with severe or unstable depression are not eligible.
- •Patients with other types of pain or conditions that may make it difficult to evaluate fibromyalgia symptoms are not eligible
- •Any subject considered at risk of suicide or self harm based on investigator judgment and/or the details of a risk assessment
研究组 & 干预措施
Pregabalin
Group 1 as Pregabalin vs. Placebo (cross over study in which period one has this group)
干预措施: Pregabalin (Drug)
Placebo
Group 2 as placebo vs. pregabalin (cross over study in which period two will have this group)
干预措施: placebo (Drug)
结局指标
主要结局
Mean NRS Pain Score at End of Period.
时间窗: End of each period, at Weeks 6 and 14
The daily pain diary consists of an 11-point numeric scale (NRS) ranging from 0 ("no pain") to 10 ("worst possible pain"). Participants describe their pain during the past 24 hours by choosing the appropriate number between 0 and 10. The endpoint mean pain scores for Period 1 and Period 2 are defined as the mean of the last 7 non-missing daily diary pain ratings while taking study medication in the double-blind phase during Period 1 and Period 2, respectively.
次要结局
- Subjective Sleep Questionnaire - Mean Subjective Wake After Sleep Onset at End of Period.(End of each period, at Weeks 6 and 14)
- HADS at End of Period.(End of each period, at Weeks 6 and 14)
- Fibromyalgia Impact Questionnaire (FIQ) Score at Baseline.(Baseline)
- Subjective Sleep Questionnaire - Mean Sleep Quality at End of Period.(End of each period, at Weeks 6 and 14)
- Subjective Sleep Questionnaire - Mean Subjective Total Sleep Time at End of Period.(End of each period, at Weeks 6 and 14)
- Subjective Sleep Questionnaire - Parameter Estimates for Subjective Number of Awakenings Per Night After Sleep Onset at End of Period.(End of each period, at Weeks 6 and 14)
- Hospital Anxiety and Depression Scale (HADS) at Baseline.(Baseline)
- EQ-5D Score at End of Period.(End of each period, at Weeks 6 and 14)
- FIQ Score at End of Period.(End of each period, at Weeks 6 and 14)
- Percentage of Participants With >=30% and >=50% Pain Reduction Based on Daily Pain Diary.(Visits 2, 6, and 12)
- Mean EuroQoL 5-Dimensions (EQ-5D) Score at Baseline.(Baseline)
- Patient Global Impression of Change (PGIC) at the End of Period 1.(End of Period 1 at Week 6)
- Subjective Sleep Questionnaire - Mean Latency to Sleep Onset at End of Period.(End of each period, at Weeks 6 and 14)