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Sublingual Methadone for the Management of Cancer-Related Breakthrough Pain in Outpatients
This study has been suspended.
Sponsored by: Alberta Cancer Board
Information provided by: Alberta Cancer Board
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

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 Breakthrough Pain in Outpatients: 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 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 Cancer Board
Investigators
Principal Investigator: Neil Hagen, MD Alberta Cancer Board
  More Information

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

Keywords provided by Alberta Cancer Board:
Sublingual Methadone
Cancer related breakthrough pain
feasibility study
Phase II/open label
Outpatients
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