CancerPhase 1NCT00125684
Bioavailability and Effectiveness of Transdermally Administered Morphine
A Phase 1 study testing morphine in people with Cancer and Pain, run by Alberta Health services at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- What is being tested?
- morphine
- How many people
- 6 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2003to Jul 2008
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Use of morphine or codeine in 3 days prior to study
- Known sensitivity to morphine
- Prior anaphylactic reaction to any opioid
- Clinically significant anemia
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- morphine
- Keywords
- transdermal morphine, cancer, pain, bioavailability, pharmacokinetics, cancer related pain, stable baseline pain, currently taking opioids
- Medical subject headings
- Neoplasms, Pain, Cancer Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
morphineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
detectable morphine levels in serum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2005 (estimated)
- Study startJul 2003
- Primary completionJul 2007
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alberta Health services
- Sponsor type
- University, hospital or other
- Collaborators
- Tom Baker Cancer Centre
- Responsible party
- Principal investigator, Rachel Syme, Alberta Health services
- Investigators
- Neil Hagen, Principal investigator, Alberta Cancerboard
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00125684
- Sponsor's protocol ID
- 10181
- Status last verified
- Aug 2011
- First submitted
- 29 Jul 2005
- Last updated
- 19 Jan 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioavailability and Effectiveness of Transdermally Administered Morphine
- ClinicalTrials.gov ID
- NCT00125684
- Acronym / sponsor ID
- 10181
- Keywords
- transdermal morphine, cancer, pain, bioavailability, pharmacokinetics, cancer related pain, stable baseline pain, currently taking opioids
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- Alberta Health servicesUniversity, hospital or other
- Collaborators
- Tom Baker Cancer Centre
- Study start
- Jul 2003
- Primary completion
- Jul 2007 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 2 Aug 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- Use of morphine or codeine in 3 days prior to study
- Known sensitivity to morphine
- Prior anaphylactic reaction to any opioid
- Clinically significant anemia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| morphine | Drug | – |
Primary outcome
detectable morphine levels in serum
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Neil Hagen principal investigator
Alberta Cancerboard
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing morphine in people with Cancer and Pain, run by Alberta Health services at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
detectable morphine levels in serum. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2012.