EUCTR2011-005377-23-ES进行中（未招募）1 期
A phase II, single-center, prospective, randomized, double-blind, parallel and placebo-controlled pilot clinical study to assess the efficacy and safety of NUTROPIN® in combination with intensive rehabilitation in adults with spinal cord injury (SCI) and growth hormone deficiency (GHD).
Guillem Cuatrecasas Cambra0 个研究点目标入组 20 人开始时间: 2012年5月21日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •-Men or women aged 18 to 50 years (inclusive)
- •-Cervical or thoracic (dorsal) spine injuries (C5-T12)
- •-Complete lesions (ASIA A) with SSEP and EMG evaluation
- •-Stability of the recovery (at least 12 months since injury)
- •-Maintenance of muscular structure (no more than 24 months since injury)
- •-Partial (<10 ng/ml) or total (<5 ng/ml) GH deficiency (assessed by GH stimulation tests)
- •-Signed informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 20
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •-Spinal cord injury of non-traumatic origin
- •-Adverse effects or hypersensitivity to GH or its excipients
- •-Lack of neurophysiological assessment/confirmation of SCI
- •-Previous very intensive rehabilitation
- •-Previous growth hormone therapy
- •-Evidence of any active malignancy or cancer in the last 5 years
- •-Acute illnesses at time of randomization
- •- Pregnancy
- •-Participation in another interventional study
- •-Inability to comply with the requirements of the study or who in the opinion of the investigator should not participate in the study
研究者
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