EUCTR2007-003249-34-FR进行中（未招募）1 期
Proof of Concept study of the efficacy and tolerability of a 4-week treatment with F13640 in patients in whom the adaptation of opioid therapy of cancer pain has failed. A prospective, multinational, multicentre, randomised, double-blind, placebo-controlled study.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 72
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
- •- Out-patient male or female
- •- Aged > 18 years and < or = 65 years
- •- Diagnosis of cancer confirmed
- •- Life expectancy > 3 months
- •- With cancer pain for more than one month
- •- Under opioid treatment for cancer pain for at least 15 days
- •- In failure of opioid therapy adaptation (oxycodone or morphine only): 24-hour recall pain intensity score > 40mm on a 0-100mm Visual Analogue Scale (VAS rest or mobilization) at the selection visit, in spite of appropriate oral opioid treatment at the maximum tolerated dose, where any adjunctive analgesic medication had been instituted before, such treatment shall be continued in an unchanged manner
- •- Average 24-hour recall pain intensity score of the last 7 days before inclusion > 40 on a 0-100 Visual Analogue Scale on a Personal Digital Assistant
- •- Record of at least 4 assessable evaluations of the 24-hour recall pain intensity score in the Patient Electronic Diary over the 7 days preceding the inclusion
- •- Chemotherapy protocol not modified within the 4 weeks period preceding Day 1- In case of chemotherapy protocol on-going, the patient has received at least 2 chemotherapy cycles before selection
- •- Normal or considered as not clinically significant laboratory safety tests and ECG parameters, on the investigator’s opinion and according to CTC grading
- •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
- •- Any clinically significant hepatic, renal, gastro-intestinal, endocrinal, cardiovascular, neurological, psychiatric or haematological history or current disease unrelated to the cause of pain which may interfere with pain evaluation and the course of the study on the investigator’s opinion
- •- Respiratory insufficiency
- •- Uncontrolled arterial hypertension, with SBP >145 mmHg and/or DBP > 95mmHg
- •- Moderate to severe major depression requiring a pharmacological treatment
- •- Radiotherapy within the 4-week period preceding Day 1, or not scheduled during the study
- •- Surgery within the 4-week period preceding Day 1, or not scheduled during the study
- •- Known hyper-reactivity or hyper-sensitivity to 5-HT agonists
- •- History of alcohol or drug abuse in the 6 months preceding the inclusion, or alcohol or drug dependence in the 2 years preceding the inclusion
- •- Patient participating in another trial with any new molecule or in the follow up period of a previous trial
- •- Opioids other than oral oxycodone or morphine
- •- Routes of opioid treatment administration other than oral way
- •- Intake of any unautorised treatment
- •- Absence of effective (pharmacological, chirurgical or IUD only) contraception in female of child-bearing potential
- •- Pregnancy or breast-feeding
研究者
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