NCT01523379No Longer Available不适用
Efficiacy of the Selctive COX-2-inhibitor Parecoxibe on the Pathological Low Pressure Pain Threshold (PPT) of Patients With Complex Regional Pain Syndrome (CRPS)
Ruhr University of Bochum0 个研究点开始时间: 2012年2月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- No Longer Available
- 发起方
研究概览
简要总结
The complex regional pain syndrom is a weighty disease that often results in a lifelong disability. Mostly this disease appears unilateral after comparatively mundane fractures or operations. In early stages CRPS shows inflammatory processes. These inflammatory components can be seen as edema and vasodilatation. These inflammatory processes lead us to the hypothesis that selective COX-2-inhibitors might help patients with CRPS.
研究设计
- 研究类型
- Expanded Access
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
- •Patients with saved diagnosis of CRPS of the upper extremity based on the current used criteria for diagnosis plus a positiv 3-phase-sceletal-scintilgraphy, if they show pathological PPT-values in QST on the ipsilateral site (Z-values > 2 in age- and gender-based Z-transformation of the raw values)• age ≥ 18 years• Existence of an age-based normal creatinin-clearance (calculated with a defined formula)
排除标准
- •Important cardiovascular illness for the purpose of heart failure (NYHA II - IV), coronary heart disease (CHD), peripheral artery occlusive disease (PAOD) or unstable hypertension (values constantly over 140/90 mm Hg)
- •Florid kidney disease
- •Cerebral disease
- •Neurological systemic disorder (exception: beginning polyneuropathy with normal values of the PPT on the opposite side)
- •Lesion of the median nerve (ipsi- oder contralateral)
- •Acute bleeding disease
- •Known ulcer of the stomach or duodenum
- •Inflammatory bowel disease
- •Positive anamnesis of a gastrointestinal bleeding in the last 5 years
- •Important hepatic dysfunction (Child- pugh > 9)
- •Hypersensitivity to the agent or to sulfonamides
- •Known allergy to acetylsalicylic acid, nonsteroidal antiinflammatory drugs or other selectiv cyclooxygenase-inhibitors
- •Pregnancy and lactation period
- •Intake of one of the following drugs (current or in the last 3 days)
- •selective-serotonin-reuptake-inhibitor
- •cetoconazole
- •rifampicin
- •phenytoin
- •carbamazepine
- •dexamethasone or other systemic corticoids
- •traditional nonsteroidal antiphlogistics
- •cyclooxygenase-inhibitors
- •immunsupressives
- •TNF-α-inhibitors
研究者
Christoph Maier
Prof. Dr.
Ruhr University of Bochum
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