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Sublingual Methadone for the Management of Cancer Breakthrough Pain

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00125294
First Posted: August 1, 2005
Last Update Posted: September 25, 2017
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.
Collaborator:
Calgary Health Region
Information provided by (Responsible Party):
AHS Cancer Control Alberta
July 29, 2005
August 1, 2005
September 25, 2017
September 2003
June 2006   (Final data collection date for primary outcome measure)
  • Determine optimal dose titration
  • Determine assessment protocol
Same as current
Complete list of historical versions of study NCT00125294 on ClinicalTrials.gov Archive Site
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Sublingual Methadone for the Management of Cancer Breakthrough Pain
Evaluation of a Dose Titration Protocol for Sublingual Methadone Hydrochloride for the Management of Cancer-related Breakthrough Pain
A dose titration protocol for sublingual methadone hydrochloride for the management of cancer-related breakthrough pain to find the optimal dose.
This is a dose titration protocol for sublingual methadone hydrochloride for the management of cancer-related breakthrough pain to find the optimal dose.
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Cancer
  • Pain
Drug: Methadone
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
January 2007
June 2006   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • > 18 years of age
  • Experiences episodes of breakthrough pain which respond to opioid therapy
  • Controlled baseline pain
  • Cognitive status sufficient for accurate completion of assessment form
  • Willing to provide written informed consent
  • Ability to hold a volume of 1 cc of water under the tongue for 5 minutes

Exclusion Criteria:

  • Currently or has received methadone during the previous week
  • Recent history of substance abuse
  • Severe respiratory impairment or other contraindications to opioids
  • Recently received therapies that had the potential to alter pain intensity or response to analgesics
  • Symptomatic anemia
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
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Canada
 
NCT00125294
17208
Calgary Health Region
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AHS Cancer Control Alberta
AHS Cancer Control Alberta
Calgary Health Region
Principal Investigator: Neil Hagen Alberta Cancerboard
AHS Cancer Control Alberta
August 2011

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