Status:
TERMINATED
Sublingual Methadone for the Management of Cancer-related Procedure Pain in Inpatients
Lead Sponsor:
Alberta Health services
Conditions:
Cancer
Pain
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this Phase II study is to determine the feasibility of the dose titration and assessment protocol in the impatient population, in the clinical setting of preventing or managing breakthr...
Eligibility Criteria
Inclusion
- Pain due to cancer or its treatment; Controlled baseline pain; episodes of predictable, treatment related pain every day that are 4"/10" in severity or greater, last 10 minutes or longer, or episodes of breakthrough pain not related to cancer treatment, and are responsive to short acting oral opioids such as morphine or hydromorphone; are able to hold a volume of 1.0cc of water under tongue for a 2-minute period; are able to provide written informed consent; are able to fill out the study forms, and are inpatients
Exclusion
- Severe underlying respiratory disease such that the investigator is wary about the risk of respiratory failure from modest doses od opioid; prior sensitivity to methadone; currently are being administered methadone; are clinically unstable or have a life expectancy of less than one month making completion of the trial unlikely; and if they do not understand English sufficiently to provide written informed consent.
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2008
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00351637
Start Date
December 1 2006
End Date
September 1 2008
Last Update
January 19 2012
Active Locations (1)
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1
Tom Baker Cancer Center
Calgary, Alberta, Canada, T2N 4N2