Know Cancer

or
forgot password

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


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

Thank you

Trial Information

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


Inclusion Criteria:



- Pain due to cancer or its treatment; controlled baseline pain;

- episodes of breakthrough pain every day that are "4/10" in severity or greater, ;

- ast 10 minutes or longer, and

- are responsive to short acting oral opioids such as morphine or hydromorphone;

- are able to hole a volume of 1.0cc of water under the tongue for a 5-minute period;
are able to provide written informed consent;

- are able to fill out the study forms

Exclusion Criteria:

- Severe underlying respiratory disease such that an investigator is wary about the
risk of respiratory failure from modest doses of opioid;

- prior sensitivity to methadone;

- currently are being administered methadone;

- have breakthrough pain that in the opinion of the investigator is likely to change
within the next seven days (recent or imminent radiation therapy to the main site of
pain,

- new chemotherapy or use of an injectable bisphosphonate likely to alter the pain, new
use corticosteroids within the past week with a corresponding change in pain, or
other interventions judged likely to alter pain);

- are clinically unstable or have a life expectancy of less than one month making
completion of the trial unlikely

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 breakthrough pain in the outpatient setting

Principal Investigator

Neil Hagen, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Alberta Health Services

Authority:

Canada: Health Canada

Study ID:

20144

NCT ID:

NCT00351715

Start Date:

July 2008

Completion Date:

September 2008

Related Keywords:

  • Cancer
  • Pain
  • Sublingual Methadone
  • Cancer related breakthrough pain
  • feasibility study
  • Phase II/open label
  • Outpatients
  • Safety/ efficacy
  • previously receiving opioids
  • speak English

Name

Location