Efficacy and Safety of Pregabalin/Tizanidine vs. Pregabalin in Patients With Fibromyalgia: a Prospective, Randomized, Open-label, Blinded Endpoint (PROBE) Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 164
- 试验地点
- 1
- 主要终点
- Average pain intensity
研究概览
简要总结
Fibromyalgia (FM) is a chronic pain syndrome characterized by widespread pain, fatigue, and emotional disorders. Its onset is related to factors such as central sensitization and imbalance of neurotransmitters. The current mainstream treatments include pregabalin, but the efficacy of pregabalin is limited, with only 25%-40% pain relief rate, and adverse reactions are common.Tizanidine is an imidazoline derivative and a centrally acting alpha-2 receptor agonist with skeletal muscle relaxant, sedative and anxiolytic properties.we carried out an open-label clinical trial in order to evaluate the efficacy and safety of combined treatment with tizanidine and pregabalin for pain in FM.
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
- None
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
- •1.Aged 18-65 years. 2.Fulfill the 2016 updated American College of Rheumatology (ACR) diagnostic criteria for fibromyalgia.
- •3.Sufficient cognitive function, visual acuity and language skills to complete questionnaires and pain diaries and to participate in telephone communication with study nurses to permit titration of the study drugs.
- •4.Experienced daily pain (≥4/10 on a numerical rating scale) for at least 3 months.
排除标准
- •1.Presence of a painful condition, including inflammatory rheumatic disease, more than 50% as severe as but distinct from fibromyalgia.
- •2.Women who are pregnant or lactating. 3.Women of childbearing potential not using adequate contraceptives. 4.End-stage kidney or liver disease. 5.Unstable cardiovascular disease (myocardial infarction within the preceding year, unstable angina, or congestive heart failure) or clinically relevant abnormal 12-lead electrocardiogram.
- •6.Any poorly controlled medical condition that, in the opinion of the investigator, would interfere with proper conduct of the trial.
- •7.Severe depression, as determined by a Beck Depression Inventory-II score of 29 or more suicidal ideation, as determined by a Beck Depression Inventory-II item 9 score of 2 or more any current major psychiatric disorder (e.g., schizophrenia, bipolar disorder) that is not well controlled.
- •8.Hypersensitivity to any of the study medications. 9.Any current alcohol or drug abuse or dependence (except nicotine and caffeine).
- •10.Those taking more than 90 mg morphine equivalents per day.
研究组 & 干预措施
Pregabalin monotherapy group
干预措施: Pregabalin (Drug)
Pregabalin with tizanidine group
干预措施: Pregabalin with tizanidine (Drug)
结局指标
主要结局
Average pain intensity
时间窗: baseline , 12 weeks
The primary outcome is change from baseline to 12 weeks of treatment in average pain intensity during the last 7 days on an 11-point rating scale (ranging from 0 = "no pain" to 10 = "unbearable pain") using the first item from the symptom part of the Fibromyalgia Impact Questionnaire Revised (FIQR)
次要结局
- Fibromyalgia Impact Questionnaire Revised(weekly(from baseline to 24 weeks))
- Medical Outcome Study Short Form 36 Health Survey (SF-36)(baseline , 4, 8, 12, 16, 20, and 24 weeks)
- The Patient's Global Assessment(baseline , 4, 8, 12, 16, 20, and 24 weeks)
- The Beck II Depression Inventory(baseline , 4, 8, 12, 16, 20, and 24 weeks)
- The Pittsburgh Sleep Quality Index(baseline , 4, 8, 12, 16, 20, and 24 weeks)
- The Hospital Anxiety and Depression Scale(baseline , 4, 8, 12, 16, 20, and 24 weeks)
- The Perceived Stress Scale(baseline , 4, 8, 12, 16, 20, and 24 weeks)
- Pain distribution(baseline , 4, 8, 12, 16, 20, and 24 weeks)
- Frequency and severity of AEs(baseline , 4, 8, 12, 16, 20, and 24 weeks)
研究者
Fang Luo
Director of Department of Pain Management
Beijing Tiantan Hospital