EUCTR2007-003249-34-BE进行中（未招募）不适用
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.
试验速览
- 阶段
- 不适用
- 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 fixed scheduled opioid treatment (oxycodone, morphine, hydromorphone or fentanyl only) for cancer pain for at least 7 days before inclusion
- •- In failure of opioid therapy adaptation (oxycodone, morphine hydromorphone or fentanyl 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 or transdermal 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
- •- AST/SGOT and ALT/SGPT less than 4 times the upper normal value
- •- Normal or considered as not clinically significant laboratory safety tests and ECG parameters, on the investigator’s opinion and according to CTC grading
- •- Radiotherapy if it does nota aim at obtaining an analgesic effect.
- •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
- •- Hypertension, with SBP >160 mmHg and/or DBP > 90mmHg;
- •- SBP < 120 mmHg
- •- Moderate to severe major depression requiring a pharmacological treatment
- •- Surgery within the 4-week period preceding Day 1, or 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, morphine, hydromorphone or fentanyl
- •- Routes of opioid treatment administration other than oral route and transdermal patch
- •- 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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