Condition category
Cancer
Date applied
01/05/2006
Date assigned
06/07/2006
Last edited
17/11/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Neil Hagen

ORCID ID

Contact details

Room 374
Heritage Medical Research Building
3330 Hospital Dr. N.W.
Calgary
T2N 4N1
Canada
neilha@cancerboard.ab.ca

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00351715

Protocol/serial number

N/A

Study information

Scientific title

Sublingual methadone for the management of cancer-related breakthrough pain in outpatients: a phase II multicentre, open label, feasibility study

Acronym

SLM OUTPT

Study hypothesis

The overall hypothesis is that sublingual methadone, once optimal dose has been reached, will relieve moderate to severe breakthrough pain within five minutes in at least half of episodes evaluated.

Ethics approval

Conjoint Health Research Ethics Board, original approval 18th May 2006; amendment approval 5th October 2006.

Study design

Open label feasibility study

Primary study design

Interventional

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Cancer-related breakthrough pain

Intervention

Sublingual methadone

Intervention type

Drug

Phase

Not Applicable

Drug names

Methadone

Primary outcome measures

To demonstrate the feasibility of a novel model to assess sublingual methadone to breakthrough pain in the outpatient setting. Specific aspects of feasibility are:
1. To demonstrate the feasibility of recruitment to a study for incident pain in the outpatient setting
2. Feasibility of dose titration in the outpatient setting
3. Feasibility of filling out the pain assessments
4. Provide preliminary evidence of efficacy
5. Provide further information to document safety of the model

Secondary outcome measures

1. To develop a model of pharmacokinetic (PK) and pharmacodynamic (PD) study of breakthrough pain
2. To develop a research tool, the Breakthrough Pain Assessment Tool (BPAT)
3. To demonstrate proof of concept, with half of patients obtaining meaningful pain reduction within five minutes of administration, when given the identified optimal dose

Overall trial start date

01/06/2006

Overall trial end date

31/12/2007

Reason abandoned

Eligibility

Participant inclusion criteria

Patients aged 18 years and older are eligible if they have:
1. Pain due to cancer or its treatment
2. Controlled baseline pain
3. Episodes of breakthrough pain every day that are 4/10 in severity or greater, last ten minutes or longer, and are responsive to short acting oral opioids such as morphine or hydromorphone
4. Able to hold a volume of 1.0 cc of water under the tongue for a five minute period
5. Able to provide written, informed consent
6. Able to fill out the study forms

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

42

Participant exclusion criteria

1. Severe underlying respiratory disease such that the investigator is wary about the risk of respiratory failure from modest doses of opioid
2. Prior sensitivity to methadone
3. Currently taking methadone
4. Breakthrough pain that in the opinion of the investigator is likely to change within the next seven days as a result of any of the following:
4.1. Recent or imminent radiation therapy to the main site of pain
4.2. New use of chemotherapy
4.3. Use of an injectable bisphosphonate likely to alter the pain
4.4. New use of corticosteroids within the past week with a corresponding change in pain
4.5. Other interventions judged likely to alter the pain
5. Are clinically unstable or have a life expectancy of less than one month making completion of the trial unlikely

Recruitment start date

01/06/2006

Recruitment end date

31/12/2007

Locations

Countries of recruitment

Canada

Trial participating centre

Room 374
Calgary
T2N 4N1
Canada

Sponsor information

Organisation

Alberta Cancer Board (Canada)

Sponsor details

1220 Standard Life Building
10405 Jasper Avenue
Edmonton
T5J 3N4
Canada
barbhisc@cancerboard.ab.ca

Sponsor type

Charity

Website

http://www.cancerboard.ab.ca/

Funders

Funder type

Charity

Funder name

Alberta Cancer Board (Canada) - Competition (ref: 4640)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Infrastructural support by Canadian Institutes of Health Research (CIHR) grant number: PET 69772 - we received funding for Difficult Pain Problems NET Grant. The monies received were to provide infrastructural support for research or network activities across Canada.

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes