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

Pain Clinical Trial

Official title:

Sublingual Methadone for the Management of Cancer-related Procedure Pain in Inpatients: a Phase II Multicenter, Open Label, Feasibility Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00351637
• Other study ID #: 20145
• Secondary ID: 22206
• Status: Terminated
• Phase: Phase 2
• First received: July 11, 2006
• Last updated: January 18, 2012
• Start date: December 2006
• Est. completion date: September 2008

Study information

• Verified date: January 2012
• Source: AHS Cancer Control Alberta
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 60
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cancer
• Pain

Intervention

Drug:
• Sublingual Methadone

Locations

Country	Name	City	State
Canada	Tom Baker Cancer Center	Calgary	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
Alberta Health Services

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	to demonstrate the feasibility of a novel model to assess sublingual methadone to relieve iatrogenic,
Primary	treatment related incident breakthrough pain.
Secondary	to develop a research tool
Secondary	the Breakthrough Pain Assessment Tool (BPAT)
Secondary	and to demonstrated proof of concept