Sublingual Methadone for the Management of Cancer-related Breakthrough Pain in Outpatients

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00351715
• Other study ID #: 20144
• Secondary ID: 22206
• Status: Terminated
• Phase: Phase 2
• Start date: July 2008
• Est. completion date: September 2008

Study information

• Verified date: October 2008
• Source: AHS Cancer Control Alberta
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breakthrough Pain
• Cancer
• Pain

Intervention

Drug:
• Sublingual Methadone

Locations

Country	Name	City	State
Canada	Tom Baker Cancer Center	Calgary	Alberta
Canada	Tom Baker Cancer Centre	Calgary	Alberta

Sponsors (2)

Lead Sponsor	Collaborator
AHS Cancer Control Alberta	University of Calgary

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	to demonstrate the feasibility of a novel model to assess sublingual methadone to breakthrough pain in the outpatient setting		12 months
Secondary	to develop a model of PK/PD study of breakthrough pain		Baseline to 5 years
Secondary	to develop a research tool, the Breakthrough Pain Assessment Tool (BPAT)		Baseline to 5 years
Secondary	to demonstrate proof of concept		Baseline to 5 years