NCT00125294

Brief Summary

A dose titration protocol for sublingual methadone hydrochloride for the management of cancer-related breakthrough pain to find the optimal dose.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for phase_1 cancer

Timeline
Completed

Started Sep 2003

Typical duration for phase_1 cancer

Status
completed

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

Study Start

First participant enrolled

September 1, 2003

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

July 29, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 1, 2005

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2006

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2007

Completed
Last Updated

September 25, 2017

Status Verified

August 1, 2011

Enrollment Period

2.8 years

First QC Date

July 29, 2005

Last Update Submit

September 21, 2017

Conditions

CancerPain

Keywords

cancer painbreakthrough painmethadonedose titrationsublingual route of administrationCancer related paincurrently taking narcotics

Outcome Measures

Primary Outcomes (2)

  • Determine optimal dose titration

  • Determine assessment protocol

Interventions

MethadoneDRUG

Eligibility Criteria

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

You may qualify if:

  • \> 18 years of age
  • Experiences episodes of breakthrough pain which respond to opioid therapy
  • Controlled baseline pain
  • Cognitive status sufficient for accurate completion of assessment form
  • Willing to provide written informed consent
  • Ability to hold a volume of 1 cc of water under the tongue for 5 minutes

You may not qualify if:

  • Currently or has received methadone during the previous week
  • Recent history of substance abuse
  • Severe respiratory impairment or other contraindications to opioids
  • Recently received therapies that had the potential to alter pain intensity or response to analgesics
  • Symptomatic anemia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

NeoplasmsPainCancer PainBreakthrough Pain

Interventions

Methadone

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

KetonesOrganic Chemicals

Study Officials

  • Neil Hagen

    Alberta Cancerboard

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 29, 2005

First Posted

August 1, 2005

Study Start

September 1, 2003

Primary Completion

June 1, 2006

Study Completion

January 1, 2007

Last Updated

September 25, 2017

Record last verified: 2011-08