NCT01315210已完成2 期
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of D-Ribose in Subjects With Fibromyalgia
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
- 110
- 试验地点
- 9
- 主要终点
- Subject's Assessment of Fatigue (NRS)
研究概览
简要总结
To evaluate the safety and to determine the efficacy of D-ribose for the amelioration of fatigue in subjects with fibromyalgia. This is a phase IIa, randomized, double-blind, placebo-controlled, multi-center, multiple dose study of D-ribose versus placebo administered at doses of 5 g three times a day (TID) over a 12-week period to subjects who are experiencing fatigue associated with a diagnosis of 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •must have a diagnosis of primary fibromyalgia, as defined by the 1990 American College of Rheumatology (ACR) Criteria for the Classification of Fibromyalgia made at least 6 weeks prior to the Pretreatment Screening Visit;
- •must have a score of ≥5 on the Subject's Assessment of Fatigue 11-point numerical rating scale (NRS) at the Pretreatment Screening and Baseline Visits;
- •if taking acetaminophen or other non-opioid analgesics, NSAIDs, fibromyalgia medications, medications to induce sleep, or prednisone ≤ 10 mg (or equivalent dose of other glucocorticoids), must be on stable dose(s) for at least 4 weeks prior to the baseline visit;
- •must have discontinued any ribose-containing products (including foods, drinks, and supplements) at least 4 weeks prior to the Pretreatment Baseline Visit.
排除标准
- •current major depressive episode (MDE);
- •has been diagnosed with any autoimmune disease;
- •has been diagnosed with type I or type II diabetes;
- •has a history of cancer, other than basal cell carcinoma, stage 1 squamous cell carcinoma or cervical carcinoma in situ, that has not been in remission for at least five years prior to the Pretreatment Screening Visit;
- •has been diagnosed with chronic fatigue syndrome.
研究组 & 干预措施
D-Ribose
Experimental
干预措施: D-Ribose Powder (Drug)
Placebo
Placebo Comparator
干预措施: Placebo Powder (Dietary Supplement)
结局指标
主要结局
Subject's Assessment of Fatigue (NRS)
时间窗: 12 Weeks
次要结局
- Subject's Assessment of Pain Intensity (NRS)(12 Weeks)
- Multidimensional Fatigue Inventory(12 Weeks)
- Revised Fibromyalgia Impact Questionnaire(12 Weeks)
- Subject's Global Impression of Change(12 Weeks)
- SF-36(12 Weeks)
研究者
研究点 (9)
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