- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00125684
Bioavailability and Effectiveness of Transdermally Administered Morphine
January 18, 2012 updated by: Rachel Syme, Alberta Health services
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.
Study Overview
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 Type
Interventional
Enrollment (Anticipated)
6
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Alberta
-
Calgary, Alberta, Canada, T2N 4N2
- Tom Baker Cancer Centre
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
detectable morphine levels in serum
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Neil Hagen, Alberta Cancerboard
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2003
Primary Completion (Actual)
July 1, 2007
Study Completion (Actual)
July 1, 2008
Study Registration Dates
First Submitted
July 29, 2005
First Submitted That Met QC Criteria
August 1, 2005
First Posted (Estimate)
August 2, 2005
Study Record Updates
Last Update Posted (Estimate)
January 19, 2012
Last Update Submitted That Met QC Criteria
January 18, 2012
Last Verified
August 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 10181 (Other Identifier: CTEP)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pain
-
University Hospital Schleswig-HolsteinZealand University Hospital; European Regional Development Fund; Design School...CompletedPain, Acute | Pain, Chronic | Pain Measurement | Pain, CancerGermany
-
Flowonix MedicalApproved for marketingBack Pain | Leg Pain | Trunk Pain | Intractable Pain | Arm Pain
-
Dow University of Health SciencesRecruitingLow Back Pain | Chronic Low-back Pain | Low Back Pain, Mechanical | Mechanical Low Back Pain | Pain, Chronic | Pain, Back | Lower Back Pain Chronic | CLBP - Chronic Low Back PainPakistan
-
Dr. Negrin University HospitalCompletedPostoperative Pain, Acute | Postoperative Pain, ChronicSpain
-
George Washington UniversityRecruitingCervical Fusion | Pain, Back | Pain, Neck | Myofacial PainUnited States
-
Universitat Jaume ICompletedPain, Acute | Pain, Chronic | OncologySpain
-
Atatürk Chest Diseases and Chest Surgery Training...RecruitingPostoperative Pain | Postoperative Pain, Acute | Postoperative Pain, Chronic | VATSTurkey
-
Janssen Research & Development, LLCCompletedPain, Radiating | Pain, Burning | Pain, Crushing | Pain, Migratory | Pain, SplittingUnited States, France, Spain, Poland, Portugal
-
susanne beckerSNSFCompletedLow Back Pain | Pain, Acute | Pain, ChronicSwitzerland
-
University of Campinas, BrazilCompletedPREGNANCY | LUMBAR BACK PAIN | PELVIC PAIN
Clinical Trials on morphine
-
Indiana UniversityCompletedNeonatal Abstinence Syndrome | Neonatal Opioid Withdrawal Syndrome | Neonatal Opioid WithdrawalUnited States
-
Javelin PharmaceuticalsCompleted
-
Javelin PharmaceuticalsCompletedPain, PostoperativeUnited States
-
University of MonastirCompletedTitrated Versus High and Low Dose Nebulized Morphine to Reduce Pain in Emergency Settings (TIMORNEB)Acute Pain | Post-Traumatic HeadacheTunisia
-
Mahidol UniversityCompletedLung Diseases | Solitary MassThailand
-
University of Colorado, DenverCompletedScoliosis | Pain Management | Spinal FusionUnited States
-
Cukurova UniversityCompleted
-
University College Hospital GalwayCompletedPain, Postoperative | Arthroplasty, Replacement, Knee
-
Javelin PharmaceuticalsCompletedPost-Operative Pain | Third Molar Extraction
-
Rijnstate HospitalCompletedTotal Hip Replacement