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.

PIERRE FABRE MEDICAMENT0 sites72 target enrollmentJanuary 22, 2008

Overview

No summary available.

Registry

who.int

Start Date

January 22, 2008

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•\- 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

•\- 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