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

NCT00351637 | Terminated Phase 2

• 2 other identifiers: 2014522206
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer; Pain

Keywords

Sublingual methadone; iatrogenic; treatment related incident breakthrough pain; feasibility study; Phase II/open-label; inpatients; Safety/efficacy; Cancer related breakthrough pain; previously receiving opioids; speak English

Outcome Measures

Primary Outcomes (2)

• to demonstrate the feasibility of a novel model to assess sublingual methadone to relieve iatrogenic,

• treatment related incident breakthrough pain.

Secondary Outcomes (3)

• to develop a research tool

• the Breakthrough Pain Assessment Tool (BPAT)

• and to demonstrated proof of concept

Interventions

Sublingual Methadone DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alberta Health services: lead

Study Sites (1)

Tom Baker Cancer Center

Calgary, Alberta, T2N 4N2, Canada

Location

MeSH Terms

Conditions

Neoplasms; Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Neil Hagen, MD

  AHS Cancer Control Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 11, 2006
• First Posted: July 13, 2006
• Study Start: December 1, 2006
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2008
• Last Updated: January 19, 2012

Record last verified: 2012-01

Locations

CA (1)