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

This study has been suspended.

( Study suspended due to low accrual )

First Received: July 11, 2006 Last Updated: October 3, 2008 History of Changes

Sponsor:	Alberta Health Services
Information provided by:	Alberta Health Services
ClinicalTrials.gov Identifier:	NCT00351637

Purpose

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.

Condition	Intervention	Phase
Cancer Pain	Drug: Sublingual Methadone	Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Sublingual Methadone for the Management of Cancer-Related Procedure Pain in Inpatients: a Phase II Multicenter, Open Label, Feasibility Study

Resource links provided by NLM:

MedlinePlus related topics: Cancer

Drug Information available for: Methadone Methadone hydrochloride

U.S. FDA Resources

Further study details as provided by Alberta Health Services:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment:	60
Study Start Date:	December 2006
Estimated Study Completion Date:	September 2008
Estimated Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00351637

Locations

Canada, Alberta
Tom Baker Cancer Center
Calgary, Alberta, Canada, T2N 4N2

Sponsors and Collaborators

Alberta Health Services

Investigators

Principal Investigator:

Neil Hagen, MD

Alberta Health Services

More Information

No publications provided

Study ID Numbers:	20145, 22206
Study First Received:	July 11, 2006
Last Updated:	October 3, 2008
ClinicalTrials.gov Identifier:	NCT00351637 History of Changes
Health Authority:	Canada: Health Canada

Keywords provided by Alberta Health Services:

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

Additional relevant MeSH terms:

Respiratory System Agents
Physiological Effects of Drugs
Central Nervous System Depressants
Narcotics
Pharmacologic Actions
Methadone
Sensory System Agents

Therapeutic Uses
Analgesics
Peripheral Nervous System Agents
Antitussive Agents
Central Nervous System Agents
Analgesics, Opioid

ClinicalTrials.gov processed this record on February 08, 2010