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Sublingual Methadone for the Management of Cancer-related Procedure Pain in Inpatients: a Phase II Multicenter, Open Label, Feasibility Study


Phase 2
18 Years
N/A
Not Enrolling
Both
Cancer, Pain

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Trial Information

Sublingual Methadone for the Management of Cancer-related Procedure Pain in Inpatients: a Phase II Multicenter, Open Label, Feasibility Study


Inclusion Criteria:



- Pain due to cancer or its treatment; Controlled baseline pain; episodes of
predictable, treatment related pain every day that are 4"/10" in severity or greater,
last 10 minutes or longer, or episodes of breakthrough pain not related to cancer
treatment, and are responsive to short acting oral opioids such as morphine or
hydromorphone; are able to hold a volume of 1.0cc of water under tongue for a
2-minute period; are able to provide written informed consent; are able to fill out
the study forms, and are inpatients

Exclusion Criteria:

- Severe underlying respiratory disease such that the investigator is wary about the
risk of respiratory failure from modest doses od opioid; prior sensitivity to
methadone; currently are being administered methadone; are clinically unstable or
have a life expectancy of less than one month making completion of the trial
unlikely; and if they do not understand English sufficiently to provide written
informed consent.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

to demonstrate the feasibility of a novel model to assess sublingual methadone to relieve iatrogenic,

Principal Investigator

Neil Hagen, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Alberta Health Services

Authority:

Canada: Health Canada

Study ID:

20145

NCT ID:

NCT00351637

Start Date:

December 2006

Completion Date:

September 2008

Related Keywords:

  • Cancer
  • Pain
  • Sublingual methadone
  • iatrogenic
  • treatment related incident breakthrough pain
  • feasibility study
  • Phase II/open-label
  • inpatients
  • Safety/efficacy
  • Cancer related breakthrough pain
  • previously receiving opioids
  • speak English

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