Patients who have failed adaptation of opioid therapy for cancer pain MedDRA version: 9.1 Level: LLT Classification code 10058019 Term: Cancer pain
Conditions
Interventions
Product Code: F13640
Pharmaceutical Form: Capsule, hard
CAS Number: 208110-64-9
Current Sponsor code: F13640
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.5-
Ph
Sponsors
PIERRE FABRE MEDICAMENT
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Out-patient male or female - Aged > 18 years and 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
Exclusion criteria
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 - 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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.;Secondary Objective: 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. ;Primary end point(s): Response to the trial defined by a decrease of at least 10 of the average (mean value on the 4 last days) of the 24 hour recall pain intensity VAS score (at rest and mobilization), between inclusion and the end of the first 2-week treatment period (Day 14 or visit of premature withdrawal). Data will be captured on a patient digital assistant (PDA). | — |
Countries
Belgium, Czech Republic, France, Hungary
Outcome results
None listed