EUCTR2008-000247-34-DE进行中（未招募）1 期
Prospektive randomisierte Phase II/III-Studie zur selektiven COX-2-Inhibition beim chronischen Subduralhämatom(Prospective randomized phase II/III study for the selective COX-2-inhibition in chronic subdural haematoma) - COXIBRAIN I
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 180
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
- •patients with chronic subdural haematomas who underwent the surgical treatment without relevante hemorrhages, age 18 years and older (no maximal age), Karnofsky index of at least 70%, written informed consent, negative pregnancy-test in fertile women with birth-controll-methods (defined pearl < 1), no participation in another AMG-study within one month prior to the participation in COXIBRAIN-study.
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •patients with acute subdural haematoma, trauma with contusio cerebri, trauma with compressio cerebri, local chemotherapy, local radiotherapy, allergy to sulfonamide or celecoxib, active gastric ulcera or bleeding, allergic reaction to ASS or NSAR including COX-2-inhibitors, severe liver disorder (albumine < 25g/dl, Child-Pugh >10), severe kidney disorder (creatinine clearance <30ml/h), inflammatory gastric/colon diseases, severe heart insufficiency (NYHA II-IV classification), coronary heart syndrom, cerebrovascular disorder, peripheral artery disease, active vaccinations six weeks prior to participation in COXIBRAIN-study, active Hep B/C infection, pregnancy, neurologic/psychiatric diseases, existing celecoxib medication
研究者
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