drugset / Trial / NCT00558870

Role of Methadone As Co-Opioid Analgesic

NCT00558870

Phase 2 Terminated 5 enrolled M.D. Anderson Cancer Center
RandomizedParallel-groupTriple-blindTreatment

Summary

Objectives: Primary Objective: To determine whether the addition of low dose methadone to morphine(in the methadone group) has a lower dose escalation index as compared to the morphine alone(in the morphine group) at Day 15 (+/- 3 days) Secondary Objectives: To determine whether individuals on the methadone arm have lower pain intensity than the morphine alone arm as demonstrated by a decrease in two points from baseline (+/- 3 days) in their ESAS score at Day 15 (+/- 3 days). To determine whether the methadone group of experiences fewer opioid induced neurotoxic side effects (including sedation, myoclonus, hallucinations, hyperalgesia and confusion) as compared to the morphine alone group at Day 15 (+/- 3 days).

Timeline

Start
2007-11
Primary completion
2015-01
Completion
2015-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Methadone Other / unclassified Oral
Comparator Morphine Other / unclassified Oral

Indications

No indication recorded.