The Efficacy of Pregabalin as a Monotherapy Versus Combined Pregabalin and Milnacipran in the Management of Fibromyalgia.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- fibromyalgia impact questionnaire (FIQ)
研究概览
简要总结
Diagnosis of fibromyalgia is complex and treatment options are limited. Pharmacological management of fibromyalgia is mainly centered on the central nervous system. In particular there is robust evidence for the use of tricyclic antidepressants (e.g., amitriptyline), anti-convulsants such as gabapentin or pregabalin and agents from the serotonin norepinephrine reuptake inhibitor (SNRI) family such as milnacipran. Aim of the work: To compare the efficacy of pregabalin agent (averopreg) alone versus combined pregabalin and serotonin norepinephrine reuptake inhibitor (milnacipran) in the management of fibromyalgia.
详细描述
Subjects: The study will include 50 patients diagnosed as having fibromyalgia according to the ACR 2010 Fibromyalgia diagnostic criteria.
Methods: Patients will be classified into two groups:
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Group 1: Patients will receive pregabalin as a monotherapy and the doses will be administered according to the treatment recommendations for fibromyalgia in the package insert, starting by 50mg twice daily increasing to 100 mg twice daily within 1 week based on efficacy and tolerability.
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Group 2: Patients will receive combined pregabalin and milnacipran and the doses will be administered according to the treatment recommendations for fibromyalgia in the package insert, starting by 50mg twice daily increasing to 100 mg twice daily within 1 week for the pregabalin and starting by 12.5 mg increasing gradually to reach 100 mg daily of milnacipran based on efficacy and tolerability.
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
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •female patients
- •diagnosed as fibromyalgia according to the 2016 revision to the 2010/2011 fibromyalgia diagnostic criteria
排除标准
- •Patients with major medical disorders or uncontrolled medical conditions
- •Patients with recent myocardial infarction or stroke,
- •Patients with active liver disease,
- •Patients with renal impairment (creatinine clearance < 60 ml/min),
- •Patients with documented autoimmune disease,
- •Patients with severe chronic obstructive pulmonary disease,
- •Patients with unstable diabetes,
- •pregnancy or breastfeeding patients
- •Patients with exposed to any investigational drug within the past 6 months
研究组 & 干预措施
G1: patients will receive pregabalin
pregabalin as a mono-therapy will be administered in increment doses for 3 months
干预措施: Pregabalin 300mg (Drug)
G2: patients will receive pregabalin and milnacipran
pregabalin and milancipran as a combination therapy will be administered in increment doses for 3 months
干预措施: Combined pregabalin 300mg and milancipran 100mg (Drug)
结局指标
主要结局
fibromyalgia impact questionnaire (FIQ)
时间窗: 3 months
assesses the overall functional ability and the impact of fibromyalgia on the patients life, with a range from 0-100, 0 indicating no functional impairment or effect of the disease on the patients life and 100 indicating a very bad and tremendous effect of fibromyalgia on the patients life
visual analogue scale (VAS) for pain
时间窗: 3 months
assesses the overall pain of fibromyalgia on a 100 mm pain scale with 0 indicating no pain and 100 indicating the worst pain ever
次要结局
- Leeds sleep evaluation questionnaire(3 months)
研究者
Yousra Hisham Abdel Fattah
Principle investigator
University of Alexandria