Sublingual Methadone for the Management of Cancer Breakthrough Pain

This study has been completed.
Sponsor:
Collaborator:
Calgary Health Region
Information provided by:
AHS Cancer Control Alberta
ClinicalTrials.gov Identifier:
NCT00125294
First received: July 29, 2005
Last updated: January 18, 2012
Last verified: August 2011

July 29, 2005
January 18, 2012
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
Endpoint Classification: Bio-availability Study
Intervention Model: Single Group Assignment
Masking: 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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
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NCT00125294
17208, Calgary Health Region
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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