Sublingual Methadone for the Management of Cancer-related Procedure Pain in Inpatients

Phase 2

Terminated

• Conditions: Cancer; Pain

• Registration Number: NCT00351637
• Lead Sponsor: Alberta Health services

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 breakthrough pain, before conducting an appropriately powered phase III study. Thus the primary purpose of this study is to determine the proportion of patients who are successfully titrated to an effective dose of sublingual methadone.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-07-11
• Study First Submitted QC: 2006-07-12
• Study First Posted: 2006-07-13
• Study Start: 2006-12
• Primary Completion: 2008-09
• Study Completion: 2008-09
• Status Verified: 2012-01
• Last Update Submitted: 2012-01-18
• Last Update Posted: 2012-01-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• 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 Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
to demonstrate the feasibility of a novel model to assess sublingual methadone to relieve iatrogenic,
treatment related incident breakthrough pain.

Secondary Outcome Measures

Name	Time	Method
to develop a research tool
the Breakthrough Pain Assessment Tool (BPAT)
and to demonstrated proof of concept

Trial Locations

Locations (1)

Tom Baker Cancer Center; 🇨🇦 Calgary, Alberta, Canada