Trial Information

Translational Studies in Analgesic Pharmacology: Analgesic Synergy in Clinical Pain. A Phase 2 Study Comparing a Single Dose of a 1:1 Combination of Methadone and Morphine With Morphine Alone in Patients With Post-operative Pain.

Rationale: Experimental data demonstrates a profound analgesic synergy between morphine and
methadone when co-administered systemically in mice. If this type of synergy can be
demonstrated in clinical pain, it will be a relatively unique example of translating
concepts of fundamental aspects of opioid actions seen in the laboratory to the clinical
area, and provide a basis for offering new and scientifically- based analgesic regimens.
This may provide better pain relief with less opioid related side effects in clinical
practice.

Purpose:

This is a randomized, double blind, parallel arm Phase II study comparing a single dose of
1:1 combination of methadone and morphine with morphine alone in patients with
post-operative pain.

- The primary objective of this randomized, double blind, parallel arm Phase II study is
to compare the analgesic effects of a combination of morphine and methadone with
morphine alone to determine synergistic activity of mu opioid analgesics in patients
with post-operative pain.

- A second goal is to further evaluate any side effects of the combination of morphine
and methadone.