EUCTR2004-003944-23-AT进行中（未招募）不适用
Acetyl salicylic acid in the treatment of patients with positive margins after surgery for cervical dysplasia grade II-III: A phase II trial - Acetyl salicylic acid and CIN II/III non in sano
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 124
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
- Female
入选标准
- •1. Surgery for CIN II/III with positive margins after surgery for CIN II/III with positive margins.
- •2. Compliant subject
- •3. Safe contraception
- •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) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Exclusion Criteria
- •Lesion related
- •1. (Micro)-Invasive Cancer
- •2. Non-compliance of patient
- •Drug related
- •1. Prior history of an adverse gastro-intestinal event (ulcer, hemorrhage)
- •2. Age > 65
- •3. Concurrent use of a different NSAID
- •4. Concurrent use of glucocorticoids
- •5. Concurrent use of anticoagulants
- •6. Concurrent use of beta-blocker
- •7. Concurrent use of lithium
- •8. Concurrent use of diuretics
- •9. Concurrent use of cyclosporin
- •10. Concurrent use of methrotrexat
- •11. Allergic reaction to sulfonamides
- •12. Allergic reaction after taking NSAIDs
- •13. Severe kidney problems with decreased renal function
- •14. Severe liver problems, hepatic disease
- •15. Uncontrolled hypertension (> 160/90 mmHg)
- •16. Asthma
- •17. Allergic reaction to acetyl salicyl acid
- •18. Hemorrhagic diathesis
- •19. Thrombocytopenia
- •20. Hemophilia
- •Clinical laboratory related
- •Hemoglobin < 11 g/dl
- •Leukocytes < 4,0 x 109/L
- •Platelet count < 100 x 109/L
- •Serum bilirubin > 1.5 x above upper cut-off value
- •Serum GOT > 1.5 x above upper cut-off value
- •Serum GPT > 1.5 x above upper cut-off value
- •Serum alcalic phosphatase > 1.5 x above upper cut-off value
- •Serum creatinine > 1.5 x above cut-off value
研究者
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