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

Sponsored by:	Alberta Cancer Board
Information provided by:	Alberta Cancer Board
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

MedlinePlus related topics: Cancer

Drug Information available for: Methadone Methadone hydrochloride

U.S. FDA Resources

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

Further study details as provided by Alberta Cancer Board:

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 Cancer Board

Investigators

Principal Investigator:

Neil Hagen, MD

Alberta Cancer Board

More Information

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

Keywords provided by Alberta Cancer Board:

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

Study placed in the following topic categories:

Naphazoline
Oxymetazoline
Methadone
Guaifenesin

Phenylephrine
Pain
Phenylpropanolamine

Additional relevant MeSH terms:

Respiratory System Agents
Sensory System Agents
Therapeutic Uses
Physiological Effects of Drugs
Central Nervous System Depressants
Narcotics

Peripheral Nervous System Agents
Analgesics
Antitussive Agents
Central Nervous System Agents
Analgesics, Opioid
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009