UlcerNCT00306020
Analgesia and Wound Healing Assessment Following Topical Morphine Applied to Patients With Cutaneous Cancer Related Pain
A study testing topical morphine in people with Ulcer and Wounds and Injuries, run by Soroka University Medical Center.
Trial summary
Cutaneous cancer-related pain is difficult to treat. These patients are often prescribed high systemic dosages of opioids. Yet, many patients continue to report pain while experiencing dose-limiting side effects. An alternative approach to systemic administration is to apply topical medications. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Ulcer, Wounds and Injuries
- What is being tested?
- topical morphine
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2006to Jun 2012
- Phase
- Interventional
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Moderate to severe resting pain (scores above 5/10).
- Stable analgesic regimen.
- No surgical interventions planned during the study period.
- Able to self-assess pain and report it.
- Hospitalized or receiving home care for Stage I; out-patients or receiving home care for Stage II.
- Wound not infected or covered with necrotic tissue.
Who cannot join
- True sensitivity to opioids
About this study
Cutaneous cancer-related pain is difficult to treat. These patients are often prescribed high systemic dosages of opioids. Yet, many patients continue to report pain while experiencing dose-limiting side effects. An alternative approach to systemic administration is to apply topical medications. The advantage of topical application is the potential of achieving good analgesia using low dosages with few, if any, systemic side effects. Current clinical data indicates, that topically applied morphine has an analgesic effect in patients with severe pain and that it may even improve wound healing. The clinical reports so far have been either case studies or double blind randomly controlled trials with a very small sample size of patients. There is still a great deal of information which is lacking about this modality of treatment regarding on the one hand, the mechanism of action and on the other, clinical issues. For example, is the mechanism of the effect actually peripheral? What is the adequate dose of analgesic medication for different types of skin conditions? Wound healing has not been quantified.
We will apply morphine topically to skin wounds of cancer and evaluate the effect of the treatment on pain, side effects, quantify wound healing, quantify morphine and its metabolites in blood and urine.
Should well controlled studies, demonstrate all or any of the peripheral effects of topical morphine, clinical application of this treatment modality would be possible. This could contribute towards better treatment of these patients, who have pain which is difficult to treat and can, at times, be intractable.
- Conditions
- Ulcer, Wounds and Injuries
- Being tested
- topical morphine
- Keywords
- Skin ulcers, Topical morphine, Chronic pain, Cancer
- Medical subject headings
- Ulcer, Wounds and Injuries, Skin Ulcer, Chronic Pain, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
topical morphineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
pain intensity reports
frequency and type of side effects
blood and urine levels of morphine and its metabolites, morphine 3- and 6-glucuronide
Secondary outcomes (2)
quantification of wound healing
change in use of regular analgesics
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2006 (estimated)
- Study startJan 2006
- Primary completionJun 2012
- Study completionJun 2012
Why it stopped: The study was withdrawn due to difficulties in recruiting appropriate patients in community clinic setting
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UlcerStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Soroka University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Israel Cancer Association
- Responsible party
- Principal investigator, Pesach Shvartzman, Soroka University Medical Center
- Investigators
- Pesach Shvartzman, Professor, Principal investigator, Ben-Gurion University of the Negev, Sial Research Center for Family Medicine and Primary Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00306020
- Sponsor's protocol ID
- SOR394105CTIL
- Status last verified
- Jul 2012
- First submitted
- 21 Mar 2006
- Last updated
- 4 Jul 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesia and Wound Healing Assessment Following Topical Morphine Applied to Patients With Cutaneous Cancer Related Pain
- ClinicalTrials.gov ID
- NCT00306020
- Acronym / sponsor ID
- SOR394105CTIL
- Conditions
- Ulcer, Wounds and Injuries
- Keywords
- Skin ulcers, Topical morphine, Chronic pain, Cancer
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study was withdrawn due to difficulties in recruiting appropriate patients in community clinic setting
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Soroka University Medical CenterUniversity, hospital or other
- Collaborators
- Israel Cancer Association
- Study start
- Jan 2006
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 22 Mar 2006 (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.
Cutaneous cancer-related pain is difficult to treat. These patients are often prescribed high systemic dosages of opioids. Yet, many patients continue to report pain while experiencing dose-limiting side effects. An alternative approach to systemic administration is to apply topical medications. The advantage of topical application is the potential of achieving good analgesia using low dosages with few, if any, systemic side effects. Current clinical data indicates, that topically applied morphine has an analgesic effect in patients with severe pain and that it may even improve wound healing. The clinical reports so far have been either case studies or double blind randomly controlled trials with a very small sample size of patients. There is still a great deal of information which is lacking about this modality of treatment regarding on the one hand, the mechanism of action and on the other, clinical issues. For example, is the mechanism of the effect actually peripheral? What is the adequate dose of analgesic medication for different types of skin conditions? Wound healing has not been quantified.
We will apply morphine topically to skin wounds of cancer and evaluate the effect of the treatment on pain, side effects, quantify wound healing, quantify morphine and its metabolites in blood and urine.
Should well controlled studies, demonstrate all or any of the peripheral effects of topical morphine, clinical application of this treatment modality would be possible. This could contribute towards better treatment of these patients, who have pain which is difficult to treat and can, at times, be intractable.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Moderate to severe resting pain (scores above 5/10).
- Stable analgesic regimen.
- No surgical interventions planned during the study period.
- Able to self-assess pain and report it.
- Hospitalized or receiving home care for Stage I; out-patients or receiving home care for Stage II.
Key exclusion criteria (1 listed)
- True sensitivity to opioids
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 |
|---|---|---|
| topical morphine | Drug | – |
Primary outcome
pain intensity reports
frequency and type of side effects
blood and urine levels of morphine and its metabolites, morphine 3- and 6-glucuronide
2 secondary outcomes
quantification of wound healing
change in use of regular analgesics
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jul 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.
Pesach Shvartzman, Professor principal investigator
Ben-Gurion University of the Negev, Sial Research Center for Family Medicine and Primary Care
Questions about this trial
What is this clinical trial studying?
A study testing topical morphine in people with Ulcer and Wounds and Injuries, run by Soroka University Medical Center.
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 6 inclusion and 1 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: withdrawn, as of the sponsor's last update on 4 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
pain intensity reports. The study lists 3 primary outcomes in all. 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 4 Jul 2012.