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NCT00125294 Clinical Trial

Sublingual Methadone for the Management of Cancer Breakthrough Pain

Pain Clinical Trial

Official title:
Evaluation of a Dose Titration Protocol for Sublingual Methadone Hydrochloride for the Management of Cancer-related Breakthrough Pain

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00125294
Other study ID # 17208
Secondary ID Calgary Health R
Status Completed
Phase Phase 1
First received July 29, 2005
Last updated September 21, 2017
Start date September 2003
Est. completion date January 2007

Study information
Verified date August 2011
Source AHS Cancer Control Alberta
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility
Status Completed
Enrollment 10
Est. completion date January 2007
Est. primary completion date June 2006
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Methadone

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
AHS Cancer Control Alberta Calgary Health Region

Outcome
Type Measure Description Time frame Safety issue
Primary Determine optimal dose titration
Primary Determine assessment protocol
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