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 |
|
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 |
|
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 |
The primary objective of the study is the enhancement of analgesia by F13640 when gradually introduced in combination with opioid treatment after 14 days to evaluated by the pourcentage (% of responders) in patients who have failed adaptation of opioid therapy for cancer pain, when administered for 2 weeks including a 7-day titration period. |
|
E.2.2 | Secondary objectives of the trial |
To evaluate if : - F13640 treatment allows decreasing cumulative opioid consumption (opioid saving) and reducing adverse effects whatever the dose administered during the treatment period. - F13640 induces a long lasting analgesic effect after the treatment period and F13640 withdrawal can cause any rebound effect in patients who have failed adaptation of opioid therapy for cancer pain, when administered for 4 weeks including a 7-day titration period. - Other secondary objectives are to assess pain relief, impact on sleep, safety and tolerability on this population during the study period.
|
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- 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 7 days at 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 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 |
|
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 investigator’s opinion - Respiratory insufficiency - Hypertension with SBP >160 mmHg and/or DBP >90 mmHg ; SBP < 120 mmHg - 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 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 |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Response to the trial 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 of 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). |
|
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 | Yes |
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 | 6 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 32 |
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 | |
E.8.9.1 | In the Member State concerned months | 14 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 14 |