Clinical Trial: Study of D-Methadone in Patients With Chronic Pain

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase I/II Study of D-Methadone in Patients With Chronic Pain

Brief Summary: The purpose of this study is to determine the safest dose of d-methadone that can be given, without causing severe side effects in most patients with chronic pain. Patients are being asked to participate in the Phase I portion of this study.

Detailed Summary:
Sponsor: Memorial Sloan Kettering Cancer Center

Current Primary Outcome: Number Who Reached a Safe Dose [ Time Frame: 2 years ]

The number of patients who reached a safe and well tolerated dose of d-methadone


Original Primary Outcome:

  • Phase I: The objective of this study is to determine a safe and well tolerated dose of d-methadone in patients with chronic pain. [ Time Frame: Once dose escalation is complete ]
  • Phase II: The objective of this study is to evaluate the analgesic efficacy of d-methadone in patients taking opioids for cancer related pain and in patients not taking opioids with cancer related neuropathic pain. [ Time Frame: conclusion of study ]


Current Secondary Outcome:

Original Secondary Outcome: The scientific aim of the study is to test safety and efficacy of a possible new non-opioid analgesic. [ Time Frame: conclusion of study ]

Information By: Memorial Sloan Kettering Cancer Center

Dates:
Date Received: December 22, 2007
Date Started: October 2004
Date Completion:
Last Updated: June 29, 2016
Last Verified: June 2016