Pilot Study for the NorCAPITAL Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Plasma concentration level (Cmax and Co) of clonidine
研究概览
简要总结
The aim of this pilot study for the NorCAPITAL trial is to investigate the feasibility and safety of the drug clonidine in adolescent chronic fatigue syndrome (CFS). Specifically, the investigators wanted to assess appropriate dosage in relation to a) plasma concentration levels of clonidine, b) orthostatic cardiovascular responses (the pulse and blood pressure responses when rising up), and c) reports of possible adverse effects.
A possible beneficial effect of clonidine in adolescent CFS will be investigated in NorCAPITAL, which is a randomized, placebo-controlled, double blind trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Persisting or constantly relapsing fatigue lasting 3 months or more
- •Functional disability resulting from fatigue to a degree that prevent normal school attendance
- •Age between 12 and 19 years
排除标准
- •Another disease process or current demanding life event that might explain the fatigue
- •Another chronic disease
- •Permanent use of drugs
- •Permanently bed-ridden
- •Positive pregnancy test
- •Supine systolic blood pressure (SBP) < 85 mm Hg
- •Fall in SPB upon standing > 30 mm Hg
- •Supine HR < 50 beats/min
- •Abnormal ECG
研究组 & 干预措施
Clonidine
干预措施: Clonidine (Drug)
结局指标
主要结局
Plasma concentration level (Cmax and Co) of clonidine
时间窗: After 14 days of treatment
次要结局
- Orthostatic cardiovascular responses (head-up tilt test)(After 14 days of treatment)
- Reports of adverse effects(Participants will be followed for the duration of treatment period, an expected average of 14 days)
- Plasma concentration (Cmax) of clonidine(First day of treatment, approximately 5 hours after the first dose)
研究者
Vegard Bruun Wyller
Associate Professor
Oslo University Hospital