NCT00125684

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for phase_1 cancer

Timeline
Completed

Started Jul 2003

Longer than P75 for phase_1 cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2003

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

July 29, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 2, 2005

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2007

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
Last Updated

January 19, 2012

Status Verified

August 1, 2011

Enrollment Period

4 years

First QC Date

July 29, 2005

Last Update Submit

January 18, 2012

Conditions

CancerPain

Keywords

transdermal morphinecancerpainbioavailabilitypharmacokineticscancer related painstable baseline paincurrently taking opioids

Outcome Measures

Primary Outcomes (1)

  • detectable morphine levels in serum

Interventions

morphineDRUG

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tom Baker Cancer Centre

Calgary, Alberta, T2N 4N2, Canada

Location

MeSH Terms

Conditions

NeoplasmsPainCancer Pain

Interventions

Morphine

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Morphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Study Officials

  • Neil Hagen

    Alberta Cancerboard

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Neil Hagen - Principal Investigator

Study Record Dates

First Submitted

July 29, 2005

First Posted

August 2, 2005

Study Start

July 1, 2003

Primary Completion

July 1, 2007

Study Completion

July 1, 2008

Last Updated

January 19, 2012

Record last verified: 2011-08

Locations

CA(1)