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Sublingual Methadone for the Management of Cancer Breakthrough Pain

NCT ID: NCT00125294

Last Updated: 2017-09-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-09-30

Study Completion Date

2007-01-31

Brief Summary

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

Detailed Description

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

Conditions

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Cancer Pain

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Methadone

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* \> 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Calgary Health Region

OTHER

Sponsor Role collaborator

AHS Cancer Control Alberta

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Neil Hagen

Role: PRINCIPAL_INVESTIGATOR

Alberta Cancerboard

Other Identifiers

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Calgary Health Region

Identifier Type: -

Identifier Source: secondary_id

17208

Identifier Type: -

Identifier Source: org_study_id