NCT00830050已完成早期 1 期
A Study To Determine The Ability Of FMRI To Detect And Quantify The Effect Of Naproxen On Osteoarthritis Of The Hand
适应症
干预措施
相关药物
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Changes in voxel-wise Blood Oxygen Level Dependent (BOLD) signal throughout the brain and changes in pre-defined brain regions of interest.
研究概览
简要总结
The study hypothesis is that the relief of pain in patients with osteoarthritis in the hand can be detected by a form of brain scanning that detects which parts of the brain are activated when pain is felt.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Right-handed, post-menopausal female, any race, 50-80 years
- •Clinical diagnosis of osteoarthritis of the hand
- •Estimated pain in this joint of at least 5 on a scale of 0 to 10
排除标准
- •Any patient who smokes more than 5 cigarettes per day
- •Patients receiving some anti-depressant drugs unless the dose is stable
- •Patients unable to be admitted or lie still in an MRI scanner
研究组 & 干预措施
Arm 1
Experimental
干预措施: Naproxen (Drug)
Arm 2
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Changes in voxel-wise Blood Oxygen Level Dependent (BOLD) signal throughout the brain and changes in pre-defined brain regions of interest.
时间窗: 22 days
次要结局
- Whole brain resting-state distribution of Cerebral Blood Flow(22 days)
- Psychometric measures of pain, namely Daily Pain Diaries and Present Pain Intensity(22 days)
- Pain induced by a grip task measured with a Visual Analogue Scale (VAS), the Short-Form McGill Pain Questionnaire and patient-rated wrist/hand evaluation (PRWHE)(22 days)
研究者
研究点 (1)
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