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

This study has been terminated.
(Study stopped due to low accrual)
Sponsor:
Information provided by:
AHS Cancer Control Alberta
ClinicalTrials.gov Identifier:
NCT00351715
First received: July 11, 2006
Last updated: January 24, 2013
Last verified: October 2008

July 11, 2006
January 24, 2013
July 2008
September 2008   (final data collection date for primary outcome measure)
to demonstrate the feasibility of a novel model to assess sublingual methadone to breakthrough pain in the outpatient setting
Same as current
Complete list of historical versions of study NCT00351715 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Sublingual Methadone for the Management of Cancer-related Breakthrough Pain in Outpatients
Sublingual Methadone for the Management of Cancer-related Breakthrough Pain in Outpatients: a Phase II Multicenter, Open Label, Feasibility Study

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.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Cancer
  • Pain
Drug: Sublingual Methadone
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
60
September 2008
September 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00351715
20144, 22206
Not Provided
Not Provided
AHS Cancer Control Alberta
Not Provided
Principal Investigator: Neil Hagen, MD AHS Cancer Control Alberta
AHS Cancer Control Alberta
October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP