E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients who have failed adaptation of opioid therapy for cancer pain. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10058019 |
E.1.2 | Term | Cancer pain |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
F13640 enhances analgesia, when gradually introduced in combination with opioid treatment after 14 days |
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E.2.2 | Secondary objectives of the trial |
- F13640 treatment allows decreasing cumulative opioid consumption and reducing adverse effects whatever the dose administered during the treatment period - F13640 induce potential long lasting analgesic effect after treatment period and F13640 withdrawal can cause any rebound effect |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Out-patient male or female - Aged  18 years and  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 7 days before inclusion - 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 Digital Assistant 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 other laboratory safety tests and ECG parameters, on the investigators opinion and according to CTC grading (grade I and grade II included) - Patient having signed the informed consent - Affiliate to the social security system or equivalent as applicable in the national regulation - Patient able and willing to use the PDA device daily for the duration of the study |
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E.4 | Principal exclusion criteria |
- 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 investigators opinion - Respiratory insufficiency - Arterial hypertension, with SBP >160 mmHg and/or DBP > 90mmHg - SBP  120 mmHg - Moderate to severe major depression requiring a pharmacological treatment - Radiotherapy within the 4-week period preceding Day 1, or 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 narcotic abuse in the 6 months preceding the inclusion, or alcohol or narcotic 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 unauthorised treatment which cannot be stopped - Woman of childbearing potential who is unwilling or unable to use a medically accepted and well documented method of contraception (e.g. chirurgical or hormonal birth control or intrauterine device only) during 2 months before the inclusion in the study , during the whole duration of the study and up to one month after the last dose of the study treatment, in order to avoid pregnancy while being exposed to the study treatment - positive pregnancy test - Pregnancy or breast-feeding - Man able to father a child unwilling or unable to practice an effective mean of birth control while participating in this study and up to one month after the last dose of the study medication. - Patient who could not be contacted |
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E.5 End points |
E.5.1 | Primary end point(s) |
Enhancement of analgesia by F13640 when gradually introduced in combination with opiod treatment after 14 days defined by a decrease of at least 10 of the 24 hour recall pain intensity VAS score (maximum of pain at rest and mobilization on each day), between inclusion (mean value on the last 7 days before inclusion) and the end of the first 2-week treatment period (mean value of the last 4 days before Day 14 or visit of premature withdrawal). Data will be captured on a Personal digital assistant (PDA). |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 3 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 1 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 1 |