Sublingual Methadone for the Management of Cancer-Related Breakthrough Pain in Outpatients

This study has been suspended.

( Study stopped due to low accrual )

First Received on July 11, 2006. Last Updated on October 6, 2008 History of Changes

Sponsor:	Alberta Health Services
Information provided by:	Alberta Health Services
ClinicalTrials.gov Identifier:	NCT00351715

Purpose

The purpose of this Phase II study is to determine the feasibility of the dose titration and assessment protocol in the outpatient population 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 optimal dose of sublingual (Under the tongue) methadone and then studied at that optimal dose with successive episodes of breakthrough pain.

Condition	Intervention	Phase
Cancer Pain	Drug: Sublingual Methadone	Phase II

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Sublingual Methadone for the Management of Cancer-Related Breakthrough Pain in Outpatients: 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 breakthrough pain in the outpatient setting

Secondary Outcome Measures:

to develop a model of PK/PD study of breakthrough pain
to develop a research tool, the Breakthrough Pain Assessment Tool (BPAT)
to demonstrate proof of concept

Estimated Enrollment:	60
Study Start Date:	July 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 breakthrough pain every day that are "4/10" in severity or greater, ;
ast 10 minutes or longer, and
are responsive to short acting oral opioids such as morphine or hydromorphone;
are able to hole a volume of 1.0cc of water under the tongue for a 5-minute period; are able to provide written informed consent;
are able to fill out the study forms

Exclusion Criteria:

Severe underlying respiratory disease such that an investigator is wary about the risk of respiratory failure from modest doses of opioid;
prior sensitivity to methadone;
currently are being administered methadone;
have breakthrough pain that in the opinion of the investigator is likely to change within the next seven days (recent or imminent radiation therapy to the main site of pain,
new chemotherapy or use of an injectable bisphosphonate likely to alter the pain, new use corticosteroids within the past week with a corresponding change in pain, or other interventions judged likely to alter pain);
are clinically unstable or have a life expectancy of less than one month making completion of the trial unlikely

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00351715

Locations

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

Sponsors and Collaborators

Alberta Health Services

Investigators

Principal Investigator:

Neil Hagen, MD

Alberta Health Services

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00351715 History of Changes
Other Study ID Numbers:	20144, 22206
Study First Received:	July 11, 2006
Last Updated:	October 6, 2008
Health Authority:	Canada: Health Canada

Keywords provided by Alberta Health Services:

Sublingual Methadone
Cancer related breakthrough pain
feasibility study
Phase II/open label

Outpatients
Safety/ efficacy
previously receiving opioids
speak English

Additional relevant MeSH terms:

Methadone
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions

Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Antitussive Agents
Respiratory System Agents
Narcotics

ClinicalTrials.gov processed this record on February 09, 2012