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 - ND

Phase 1

• Conditions: Patients who have failed adaptation of opioid therapy for cancer pain.; MedDRA version: 9.1 Level: LLT Classification code 10058019 Term: Cancer pain

• Registration Number: EUCTR2007-003249-34-IT
• Lead Sponsor: Pierre Fabre Medicament

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-02-11
• Study Completion: 2008-11-03
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 72

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 investigator?s 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
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

- 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 - 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified