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 ]
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