Bioavailability and Effectiveness of Transdermally Administered Morphine

NCT ID: NCT00125684

Last Updated: 2012-01-19

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

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-07-31

Study Completion Date

2008-07-31

Brief Summary

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Patients will participate in two arms of the trial, one in which morphine will be administered transdermally, and, after a 3 day wash out period, one in which morphine will be administered subcutaneously.

Detailed Description

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Patients will participate in two arms of the trial, one in which morphine will be administered transdermally, and, after a 3 day wash out period, one in which morphine will be administered subcutaneously. Blood draws will be done after both dosing methods in order to compare blood levels of morphine by the different routes.

Conditions

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Cancer Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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morphine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Chronic cancer pain
* Minimum baseline pain of 3/10
* No change in medications over 3 days prior to study period
* Ability to give informed consent
* Willingness to undergo repeated blood sampling

Exclusion Criteria

* Use of morphine or codeine in 3 days prior to study
* Known sensitivity to morphine
* Prior anaphylactic reaction to any opioid
* Clinically significant anemia
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tom Baker Cancer Centre

OTHER

Sponsor Role collaborator

Alberta Health services

OTHER

Sponsor Role lead

Responsible Party

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Rachel Syme

Dr. Neil Hagen - Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Neil Hagen

Role: PRINCIPAL_INVESTIGATOR

Alberta Cancerboard

Locations

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Tom Baker Cancer Centre

Calgary, Alberta, Canada

Site Status

Countries

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Canada

Other Identifiers

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10181

Identifier Type: -

Identifier Source: org_study_id

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