EUCTR2004-003824-36-ES进行中（未招募）不适用
Randomized, double blind, parallel groups, placebo controlled pivotal clinical trial to asses preliminary efficacy and security of a sublingual Cannabis Standardized Extract (Sativex) added to reference treatment for prevention and treatment of nausea and late vomiting induced by moderately emetogenic chemotherapy. - SATEME-08
Fundació Institut Català de Farmacologia0 个研究点开始时间: 2005年9月5日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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
- •â€¢18 years or older
- •â€¢Solid malignancy diagnosed to be treated with 1st line chemotherapy (2nd cycle) mildly emetogenic. (1 day carboplatin/cisplatin/ciclophosfamide, doxorubicine, idarrubicine, irinotecan, mitoxantrona or epirrubicine) combine or in monotherapy.
- •â€¢Patients with at least 1 vomit/day and nausea scored > 25 mm EAV despite antiemetiec prophylaxis treatment.
- •â€¢Patients receiving prophylaxis treatment for late vomits and nausea
- •â€¢Karnofsky scale = or >70
- •â€¢Haematological and metabolic condition stable enough to receive the chemotherapy.
- •Leuco > 3000/mm3
- •Platls >100.000/mm3
- •Serum Creatinine <1,5 mg/dl
- •â€¢Able to complete questionnaires, diary and visual scale.
- •â€¢Patien having given 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
- •â€¢more than 1 chemotherapy cycle. Biologic or hormonal therapies are permitted.
- •â€¢Background of hypersensitivity to cannabinoids.
- •â€¢cannabinoids use within 30d before inclusion
- •â€¢Systemic corticosteroid treatment within 72h before 1st dose of study medication (only accepted if pre-treatment to chemotherapy)
- •â€¢Patients receiving abdominal or pelvic radiotherapy within 7 days before study drug 1ss dose or so scheduled for the following 6 days
- •â€¢Patients with vomits and nauseas due to known reason including (but no limited): GI obstruction, intracranial pressure, hypocalcaemia, active peptic ulcers.
- •â€¢Patients with active systemic infection or any other uncontrolled conditions (apart from cancer) that according to investigator judgement could affect patient security or study results
- •â€¢Patients with AST and or ALT>2,5 x UNL without diagnosed hepatic metastasis (or x5 if hepatic affection diagnosed)
- •â€¢Patients receiving investigational drug within 30days before inclusion or willing to receive it during the study period.
- •â€¢Drug / Alcohol abuse background (Confirmed Test Insta-Check)
- •â€¢History of cardiovascular illness.
- •â€¢Cognitive deterioration affecting patient collaboration.
- •â€¢Severe psychiatric illness (schizophrenia, severe depression, etc..).
- •â€¢Pregnant or breast-feeding woman
- •â€¢Driving needs or dangerous engine managementneeds.
研究者
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