Epidermylosis BullosaPhase 4NCT00231517
Randomised Double Blind Placebo Controlled Cross Over Design of the Efficacy of Topical Morphine for Inflammatory Pain in Children With Epidermolysis Bullosa
A Phase 4 study testing topical opiod and morphine sulphate in intrasite gel in people with Epidermylosis Bullosa, run by Institute of Child Health at 1 site in United Kingdom.
Trial summary
Randomised Double blind placebo controlled cross over design study of the efficacy of morphine for inflammatory pain in children with Epidermolysis Bullosa Read more about this study
- Who is it for?
- Ages 4 to 18 years
- Conditions the study is for
- Epidermylosis Bullosa
- What is being tested?
- topical opiod and morphine sulphate in intrasite gel
- How many people
- Not given
- Where
- 1 siteUnited Kingdom
- Study dates
- Start not givento not given
- Phase
- Phase 4
- 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 4 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- children under 18 years epidermolysis wounds requiring dressing changes
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Great Ormond Street Hospital and the Institute of Child health
London, WC1N 1EH
About this study
Randomised Double blind placebo controlled cross over design study of the efficacy of morphine for inflammatory pain in children with Epidermolysis Bullosa
- Conditions
- Epidermylosis Bullosa
- Being tested
- topical opiod, morphine sulphate in intrasite gel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
topical opiodDrug
morphine sulphate in intrasite gelDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2005 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epidermylosis BullosaStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- Institute of Child Health
- Sponsor type
- University, hospital or other
- Investigators
- Richard Howard, Prof, Principal investigator, Institute of Child Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00231517
- Sponsor's protocol ID
- 01MH17
- Status last verified
- Oct 2005
- First submitted
- 3 Oct 2005
- Last updated
- 12 Oct 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Double Blind Placebo Controlled Cross Over Design of the Efficacy of Topical Morphine for Inflammatory Pain in Children With Epidermolysis Bullosa
- ClinicalTrials.gov ID
- NCT00231517
- Acronym / sponsor ID
- 01MH17
- Conditions
- Epidermylosis Bullosa
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Institute of Child HealthUniversity, hospital or other
- First posted
- 4 Oct 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.
Randomised Double blind placebo controlled cross over design study of the efficacy of morphine for inflammatory pain in children with Epidermolysis Bullosa
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 4 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- children under 18 years epidermolysis wounds requiring dressing changes
Key exclusion criteria (0 listed)
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 opiod | Drug | – |
| morphine sulphate in intrasite gel | 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 12 Oct 2006.
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.
Richard Howard, Prof principal investigator
Institute of Child Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing topical opiod and morphine sulphate in intrasite gel in people with Epidermylosis Bullosa, run by Institute of Child Health at 1 site in United Kingdom.
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 1 inclusion and 0 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 12 Oct 2006. 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 United Kingdom. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
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 12 Oct 2006.