ISRCTN18278231进行中（未招募）3 期
Clinical trial of a melatonin-pregabalin combination for fibromyalgia
适应症
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 54
研究概览
简要总结
2024 Protocol article in https://pubmed.ncbi.nlm.nih.gov/38910006/ (added 25/06/2024)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Participants =18 years old and over meeting the 2016 American College of Rheumatology diagnostic criteria for fibromyalgia
- •2. Daily moderate pain (= 3/10) for at least 3 months
- •3. Liver function test, ALT, no greater than 20% above normal
- •4. Creatinine clearance >50 mL/min
- •5. Sufficient cognitive function and language comprehension skills – regardless of native language – for questionnaire completion and communication with trial personnel (and translator, if necessary)
- •6. Women of childbearing potential will be required to receive a highly effective form of contraception
排除标准
- •1. Participants with any major organ system disease, psychiatric, suicidal ideation or substance abuse disorder, which, in the opinion of the investigators, would interfere with trial participation
- •2. Hypersensitivity to any of the study medications
- •3. Other painful conditions as severe as fibromyalgia pain
- •4. Shift workers who work during typical sleeping hours
- •5. Any other abnormalities or conditions that, in the judgement of the investigators would interfere with the protocol
研究者
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