NCT00497562已完成2 期
Exploratory Study to Investigate the Efficacy and Safety of Recombinant Growth Hormone as Add-on Treatment in Patients With Severe Fibromialgia
Centro Medico Teknon2 个研究点 分布在 1 个国家开始时间: 2004年5月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 试验地点
- 2
- 主要终点
- reduction number of tender points (paired)
研究概览
简要总结
There are evidences of functional growth hormone (GH) deficiency, expressed by means of low serum levels of insulin-like growth factor 1 (IGF-1), in a subset of fibromyalgia patients. The efficacy of low GH doses versus placebo has been demonstrated in this population. We assessed the efficacy and safety of GH added to standard therapy compared to standard therapy alone in the treatment of severe, prolonged and well-treated fibromialgya patients with low IGF-1 levels.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Women greater than 18 years old with severe fibromyalgia and abnormally low IGF-1 levels included in a rehabilitation and psychological program and stable under standard intensive treatment for at least 6 months.
- •All patients fulfilled the 1990 ACR diagnostic criteria (1) and had an IGF-1 level <250 ng/mL (or 1 standard deviation bellow the mean value corresponding to age and body surface according to laboratory reference value).
- •Other inclusion criteria were duration of fibromyalgia of 1 year or greater, pain in at least 16 (8 bilateral) of the 18 tender points and a score in the FIQ >
- •The study was conducted in accordance with the Declaration of Helsinki and received the local institutional review board and Spanish Drug Agency (nº03-0456) approvals. All patients gave written informed consent prior to their inclusion in the study.
排除标准
- •Disabling physical or mental status
- •Previous or current malignancies, either active or inactive
- •Intracranial space occupying lesion
- •Any relevant endocrine disorder including diabetes mellitus
- •History of another pituitary disorder
- •Previous treatment with growth hormone
- •Other systemic or joint inflammatory rheumatic conditions; and
- •Known to be hypersensitive to somatropin or any of the excipients.
- •Pregnant women, nursing mothers, or women with childbearing potential not using adequate contraceptive methods were also excluded.
结局指标
主要结局
reduction number of tender points (paired)
时间窗: one year treatment
次要结局
- improvement in FIQ, EQ-5D , analogic visual scales (1). Safety (2).(one year)
研究者
研究点 (2)
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