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Sponsored by: |
Alberta Cancer Board |
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Information provided by: | Alberta Cancer Board |
ClinicalTrials.gov Identifier: | NCT00351715 |
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.
Condition | Intervention | Phase |
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Cancer Pain |
Drug: Sublingual Methadone |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Sublingual Methadone for the Management of Cancer-Related Breakthrough Pain in Outpatients: a Phase II Multicenter, Open Label, Feasibility Study |
Estimated Enrollment: | 60 |
Study Start Date: | July 2006 |
Estimated Study Completion Date: | September 2008 |
Estimated Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Canada, Alberta | |
Tom Baker Cancer Center | |
Calgary, Alberta, Canada, T2N 4N2 | |
Tom Baker Cancer Centre | |
Calgary, Alberta, Canada |
Principal Investigator: | Neil Hagen, MD | Alberta Cancer Board |
Study ID Numbers: | 20144, 22206 |
Study First Received: | July 11, 2006 |
Last Updated: | October 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00351715 |
Health Authority: | Canada: Health Canada |
Sublingual Methadone Cancer related breakthrough pain feasibility study Phase II/open label Outpatients |
Safety/ efficacy Cancer related breakthrough pain previously receiving opioids speak English |
Naphazoline Oxymetazoline Methadone Guaifenesin |
Phenylephrine Pain Phenylpropanolamine |
Respiratory System Agents Sensory System Agents Therapeutic Uses Physiological Effects of Drugs Central Nervous System Depressants Narcotics |
Peripheral Nervous System Agents Analgesics Antitussive Agents Central Nervous System Agents Analgesics, Opioid Pharmacologic Actions |