drugset / Trial / NCT01793480

Evaluation of the Efficacy and Safety of Two Methadone Titration Methods for the Treatment of Cancer-related Pain With Inadequate Pain Relief or Intolerable Side Effects When Treated With Level 3 Opioids.

NCT01793480

Phase 3 Completed 146 enrolled RECORDATI GROUP
RandomizedParallel-groupOpen-labelTreatment

Summary

This is a multicentric, randomized, open-label, phase IIIb national study, to evaluate the clinical effects (success/failure) of methadone for the treatment of cancer-related-pain in patients with inadequate pain relief or intolerable side effects when treated with level 3 opioid. Principal objective is to compare the clinical effects (success/failure) of two methods of methadone titration in patients with cancer-related pain inadequately relieved or with intolerable side effects after treatment with level 3 opioid. Secondary objectives are : Overall safety of methadone during the study, to describe the patients' characteristics, to describe the effects of methadone on pain relief, to describe the methadone administration, to evaluate patient's quality of life, to evaluate the prescriber's opinion regarding the handling of methadone initiation.

Timeline

Start
2012-01-05
Primary completion
2014-05-06
Completion
2014-08-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Methadone Other / unclassified

Indications

No indication recorded.