Bioavailability and Effectiveness of Transdermally Administered Morphine

Condition(s) targeted: Cancer; Pain

Intervention: morphine (Drug)

Phase: Phase 1

Status: Recruiting

Sponsored by: Alberta Cancer Board

Official(s) and/or principal investigator(s):
Neil Hagen, Principal Investigator, Affiliation: Alberta Cancerboard

Overall contact:
Carla Stiles, Phone: 403-210-8243, Email: carla.stiles@calgaryhealthregion.ca

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.

Official title: Bioavailability and Effectiveness of Transdermally Administered Morphine

Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Bio-availability Study

Primary outcome: detectable morphine levels in serum

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.

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

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

Carla Stiles, Phone: 403-210-8243, Email: carla.stiles@calgaryhealthregion.ca

Tom Baker Cancer Centre, Calgary, Alberta T2N 4N2, Canada; Recruiting
Rachel Syme, PhD

Starting date: July 2003
Ending date: July 2007
Last updated: November 15, 2007