Decubitus UlcerPhase 1/2NCT00007254
Morphine Gel for Bedsores
A Phase 1/2 study testing Pain relief for pressure ulcers in people with Decubitus Ulcer, run by University of Kansas at 2 sites in United States.
Trial summary
This study tests the effectiveness of a morphine-containing gel for reducing pain caused by pressure ulcers, also known as bedsores or pressure sores. We will apply the gel containing morphine, or the gel alone, directly onto painful pressure ulcers and compare the results. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Decubitus Ulcer
- What is being tested?
- Pain relief for pressure ulcers
- How many people
- 75 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2000to Feb 2003
- Phase
- Phase 1/2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Presence of a Stage II pressure ulcer.
- Pressure ulcer must be painful.
- Primary Care physician must approve participation.
- Thinking ability must be clear and intact.
- Willing to change pain medication to oxycodone.
Who cannot join
- Allergy to morphine, oxycodone or intrasite gel.
- Use of codeine- or morphine-containing medications.
- Use of pain medications for anything other than the pressure ulcer.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
The University of Kansas Medical Center
Kansas City, Kansas, 66160
Kindred Hospital
Kansas City, Missouri
About this study
Official title: Morphine-Infused Gel for Pressure Ulcer Analgesia
This study tests the effectiveness of a morphine-containing gel for reducing pain caused by pressure ulcers, also known as bedsores or pressure sores. We will apply the gel containing morphine, or the gel alone, directly onto painful pressure ulcers and compare the results.
Read the detailed description
In this study, we will apply a morphine-containing gel (or placebo) directly onto painful pressure ulcers. We will take participants off of any opioid-containing medications upon entry into the study. This allows us to measure any morphine that may enter into the bloodstream from the topically applied gel.
The purpose of this study is to examine the efficacy of the gel for pressure ulcer analgesia, as well as the systemic absorption of morphine from the topically applied gel. We will document the amount of pain medications taken by participants to determine whether the gel decreases the need for these drugs.
- Conditions
- Decubitus Ulcer
- Being tested
- Pain relief for pressure ulcers
- Keywords
- Analgesia, Bedsore, Morphine gel, Pressure ulcer, Pain, Ulcer
- Medical subject headings
- Pressure Ulcer, Agnosia, Pain, Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain relief for pressure ulcersDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2000 (estimated)
- Study startMar 2000
- Study completionFeb 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Decubitus 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 75 participants
Sponsor and investigators
- Lead sponsor
- University of Kansas
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Investigators
- Teresa D. Long, MD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00007254
- Sponsor's protocol ID
- R01AR045506
- Other IDs
- R01AR045506, NIAMS-061
- Status last verified
- May 2013
- First submitted
- 16 Dec 2000
- Last updated
- 20 May 2013
- Results posted
- No
Publications
Twillman RK, Long TD, Cathers TA, Mueller DW. Treatment of painful skin ulcers with topical opioids. J Pain Symptom Manage. 1999 Apr;17(4):288-92. doi: 10.1016/s0885-3924(98)00140-7.
PubMed 10203881
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Morphine-Infused Gel for Pressure Ulcer Analgesia
- ClinicalTrials.gov ID
- NCT00007254
- Acronym / sponsor ID
- R01AR045506
- Conditions
- Decubitus Ulcer
- Keywords
- Analgesia, Bedsore, Morphine gel, Pressure ulcer, Pain, Ulcer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants
- Lead sponsor
- University of KansasUniversity, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Study start
- Mar 2000
- Study completion
- Feb 2003
- First posted
- 18 Dec 2000 (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.
This study tests the effectiveness of a morphine-containing gel for reducing pain caused by pressure ulcers, also known as bedsores or pressure sores. We will apply the gel containing morphine, or the gel alone, directly onto painful pressure ulcers and compare the results.
Detailed description
In this study, we will apply a morphine-containing gel (or placebo) directly onto painful pressure ulcers. We will take participants off of any opioid-containing medications upon entry into the study. This allows us to measure any morphine that may enter into the bloodstream from the topically applied gel.
The purpose of this study is to examine the efficacy of the gel for pressure ulcer analgesia, as well as the systemic absorption of morphine from the topically applied gel. We will document the amount of pain medications taken by participants to determine whether the gel decreases the need for these drugs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Presence of a Stage II pressure ulcer.
- Pressure ulcer must be painful.
- Primary Care physician must approve participation.
- Thinking ability must be clear and intact.
- Willing to change pain medication to oxycodone.
Key exclusion criteria (3 listed)
- Allergy to morphine, oxycodone or intrasite gel.
- Use of codeine- or morphine-containing medications.
- Use of pain medications for anything other than the pressure ulcer.
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 |
|---|---|---|
| Pain relief for pressure ulcers | Drug | – |
Primary outcome
Not reported in the source record.
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 20 May 2013.
- Background: PubMed 10203881Twillman RK, Long TD, Cathers TA, Mueller DW. Treatment of painful skin ulcers with topical opioids. J Pain Symptom Manage. 1999 Apr;17(4):288-92. doi: 10.1016/s0885-3924(98)00140-7.
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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.
Teresa D. Long, MD principal investigator
University of Kansas Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Pain relief for pressure ulcers in people with Decubitus Ulcer, run by University of Kansas at 2 sites in United States.
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 3 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 20 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00007254, which also lists 1 linked publication.
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 20 May 2013.