Bioavailability and Effectiveness of Transdermally Administered Morphine

Phase 1

Completed

• Conditions: Cancer; Pain

• Registration Number: NCT00125684
• Lead Sponsor: Alberta Health services

Brief Summary

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

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.

Study Timeline

• Study Start: 2003-07
• Study First Submitted: 2005-07-29
• Study First Submitted QC: 2005-08-01
• Study First Posted: 2005-08-02
• Primary Completion: 2007-07
• Study Completion: 2008-07
• Status Verified: 2011-08
• Last Update Submitted: 2012-01-18
• Last Update Posted: 2012-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
detectable morphine levels in serum

Trial Locations

Locations (1)

Tom Baker Cancer Centre; 🇨🇦 Calgary, Alberta, Canada