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

This study has been terminated.
(Study stopped due to low accrual)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00351715
First Posted: July 13, 2006
Last Update Posted: January 28, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
AHS Cancer Control Alberta
July 11, 2006
July 13, 2006
January 28, 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
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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
Intervention Model: Single Group Assignment
Masking: None (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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
 
NCT00351715
20144
22206
Not Provided
Not Provided
Not Provided
Not Provided
Alberta Health Services
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