EUCTR2004-001789-42-ES进行中（未招募）1 期
A MULTICENTRE CLINICAL TRIAL EVALUATING THE ANALGESIC EFFICACY AND SAFETY OF DEXKETOPROFEN TROMETAMOL (50 mg i.v. FOLLOWED BY AN ORAL DOSAGE OF 25 mg t.i.d.) VERSUS METAMIZOL (2 g i.v. and 575 mg t.i.d. BY ORAL ROUTE) FOR THE TREATMENT OF PAIN SUBSEQUENT TO AMBULATORY MAJOR SURGERY
aboratorios Menarini, S.A.0 个研究点目标入组 160 人开始时间: 2004年11月22日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 160
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
- •1. Aged between18 and 65 years old (both inclusive).
- •2. Grade I or II ASA physical status (American Society of Anaesthesiologists Scale).
- •3. Patients scheduled to undergo ambulatory major surgery consisting in non-relapsed unilateral inguinal mesh hernioplasty with intradural anaesthesia.
- •4. Patients who are able to understand the patient information sheet and who have provided written informed consent.
- •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
- •1. Chronic treatment with opiates and/or NSAIDs.
- •2. Systemic or local surgical wound infection prior to the surgical procedure
- •3. History of peptic ulcer, NSAID-related gastropathy or gastrointestinal bleeding
- •4. Hypersensitivity or intolerance to acetylsalicylic acid, dexketoprofen, metamizol or other NSAIDs
- •5. Asthmatic patients or patients with history of bronchospasm, angioedema or nasal polyps
- •6. Patients with severe renal or hepatic failure
- •7. Patients with non-controlled diabetes, heart failure or hypertension
- •8. Blood coagulation disorders
- •9. Patients with any currently treated psychiatric disorder, such as endogenous depression, psychotic condition and/or bipolar disorder
- •10. Patients with Crohn’s disease, ulcerous colitis, acute intermittent porphyria or glucose-6-phosphate-dehydrogenase birth deficiency.
- •11. Patients receiving concomitant treatment or who have received treatment within 4 days prior to the surgical intervention with:
- •Oral glycaemia lowering agentsOral anticoagulants
- •Antiepileptic agents Methotrexate
- •Tricyclic antidepressants Cyclosporine
- •Antipsychotic agents Lithium
- •12. Clinically significant abnormalities on requested complementary pre-operative examinations
- •13. Suspected alcohol or drug abuse.
- •14. Inability to understand the nature of the study or to collaborate in its conduct
- •15. Patients receiving concomitant treatment with other investigational drugs or who have participated in another clinical trial within two months prior to study entry
- •16. Pregnant or breastfeeding women. A pregnancy test will be performed to all women of childbearing potential, who must have a negative result to be included in the study.
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