Sublingual Methadone for the Management of Cancer Breakthrough Pain
Information source: Alberta Cancer Board
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cancer; Pain
Intervention: Methadone (Drug)
Phase: Phase 1
Status: Recruiting
Sponsored by: Alberta Cancer Board Official(s) and/or principal investigator(s):
Neil Hagen, Principal Investigator, Affiliation: Alberta Cancerboard
Overall contact:
Carla Stiles, Phone: 403-210-8423, Email: carla.stiles@calgaryhealthregion.ca
Summary
A dose titration protocol for sublingual methadone hydrochloride for the management of
cancer-related breakthrough pain to find the optimal dose.
Clinical Details
Official title: Evaluation of a Dose Titration Protocol for Sublingual Methadone Hydrochloride for the Management of Cancer-Related Breakthrough Pain
Study design: Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Bio-availability Study
Primary outcome: Determine optimal dose titrationDetermine assessment protocol
Detailed description:
This is a dose titration protocol for sublingual methadone hydrochloride for the management
of cancer-related breakthrough pain to find the optimal dose.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Carla Stiles, Phone: 403-210-8423, Email: carla.stiles@calgaryhealthregion.ca
Tom Baker Cancer Centre, Calgary, Alberta T2N 4N2, Canada; Recruiting
Rachel Syme, Phone: 403-521-3388, Email: clinical_trials-tbcc@cancerboard.ab.ca
Neil Hagen, Principal Investigator
Additional Information
Starting date: September 2003
Ending date: December 2005
Last updated: August 13, 2008
|
