NCT00351715

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for phase_2 cancer

Timeline
Completed

Started Jul 2008

Shorter than P25 for phase_2 cancer

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 11, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 13, 2006

Completed
2 years until next milestone

Study Start

First participant enrolled

July 1, 2008

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
Last Updated

October 21, 2019

Status Verified

October 1, 2008

Enrollment Period

2 months

First QC Date

July 11, 2006

Last Update Submit

October 17, 2019

Conditions

CancerPain

Keywords

Sublingual MethadoneCancer related breakthrough painfeasibility studyPhase II/open labelOutpatientsSafety/ efficacypreviously receiving opioidsspeak English

Outcome Measures

Primary Outcomes (1)

  • to demonstrate the feasibility of a novel model to assess sublingual methadone to breakthrough pain in the outpatient setting

    12 months

Secondary Outcomes (3)

  • to develop a model of PK/PD study of breakthrough pain

    Baseline to 5 years

  • to develop a research tool, the Breakthrough Pain Assessment Tool (BPAT)

    Baseline to 5 years

  • to demonstrate proof of concept

    Baseline to 5 years

Study Arms (1)

Pharmacokinetic

EXPERIMENTAL

One episode of breakthrough pain was to be evaluated per patient. Clinical status and bloodwork was evaluated prior to entering into this phase of the trial, and patients were eligible if bloodwork demonstrated a HgB of \>90 g/L with no concurrent bleeding. A peripheral intravenous catheter was inserted and saline locked. When breakthrough pain was experienced, methadone was administered, and the patient completed a pain intensity numeric rating scale at time 0 and every 10 minutes for one hour. A 10 cc specimen of blood was collected prior to administration of methadone, and again every 10 minutes for one hour. Blood was collected without anticoagulant, allowed to clot, separated by centrifugation, and serum samples flash frozen. Serum methadone levels were quantified by LC/MS/MS with comparison to isotopically labeled internal standards

Drug: Sublingual Methadone

Interventions

Sublingual MethadoneDRUG
Pharmacokinetic

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Tom Baker Cancer Center

Calgary, Alberta, T2N 4N2, Canada

Location

Tom Baker Cancer Centre

Calgary, Alberta, Canada

Location

MeSH Terms

Conditions

NeoplasmsPain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Neil Hagen, MD

    AHS Cancer Control Alberta

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 11, 2006

First Posted

July 13, 2006

Study Start

July 1, 2008

Primary Completion

September 1, 2008

Study Completion

September 1, 2008

Last Updated

October 21, 2019

Record last verified: 2008-10

Locations

CA(2)