BurnsPhase 2BURN HELPNCT00934947
Burn Healing and Analgesia With Propranolol
A Phase 2 study testing Propranolol and Propanolol in people with Burns and Pain, run by University of North Carolina, Chapel Hill at 4 sites in United States.
Trial summary
The purpose of this study is to investigate the ability of propranolol to decrease pain and improve recovery in burn patients with a common genotype. Read more about this study
- Who is it for?
- Ages 18 to 59 years
- What is being tested?
- Propranolol and Propanolol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 4 sitesUnited States
- Study dates
- Jul 2009to Jun 2011
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Thermal burn
- Greater than or equal to 18 years of age
- Less than 60 years of age
- Able to speak and read English
Who cannot join
- Intubated
- Clinically unstable
- Other substantial comorbid injury (e.g. long bone fracture)
- Heart block greater than first degree (EKG)
- History of coronary artery disease
- History of congestive heart failure
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- Asthma (within past 10 years, induced by a beta-blocker, or receiving current treatment)
- Pregnant
- Prisoner
- Psychotic, suicidal, or homicidal
- Diabetic
- Hepatic failure (acute or chronic)
- Renal failure (acute or chronic)
- History of hyperthyroidism unless taking synthroid or other thyroid hormone replacement
- Exceeds daily acceptable chronic opioid use prior to burn
- Interacting medication
- Received propranolol within the last 6 months
- Multiple severe allergic reactions
- On daily methylphenidate or similar stimulant medication
- Unwilling to use medically acceptable birth control (if childbearing potential)
- Breastfeeding
- Severe peripheral vascular disease or vasospastic disorder
- Bradycardia that in the opinion of the investigator would constitute too great a risk when considered in the context of the patient's medical comorbidities and health history
- Other criteria that in investigator's opinion makes participant poor candidate for the trial
- Cancer (except basal cell cancer)
Trial locations and contacts
4 sites in 1 country.
United States4 sites
North Carolina Jaycee Burn Center
Chapel Hill, North Carolina, 27514
Crozer Chester Medical Center
Upland, Pennsylvania, 19102
Wake Forest University Baptist
Wake Forest, North Carolina, 27587
Washington Hospital Center
Washington D.C., District of Columbia, 20011
About this study
Official title: The BURN HELP Trial: BURN Healing and AnaLgesia With Propranolol
The purpose of this study is to investigate the ability of propranolol to decrease pain and improve recovery in burn patients with a common genotype.
- Being tested
- Propranolol, Placebo, Propanolol
- Keywords
- Burns, Pain
- Medical subject headings
- Burns, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropranololDrug
Also called Inderal, Innopran
40 mg
PlaceboDrug
Also called Sugar pill
sugar pill
PropanololDrug
Also called Inderal, Innopran
120 mg twice per day
| Study group | Role | What they receive |
|---|---|---|
| Sugar pill | Placebo comparator | Not described Receives: Drug: Placebo |
| Propranolol, Propanolol ER | Experimental | Not described Receives: Drug: Propranolol; Drug: Propanolol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Pain Trajectory Slopes
Overall pain trajectory slopes by treatment group, where linear mixed modeling was used to combine pain measurements (waking, worst, and least pain) assessed on primary outcome days into an overall pain score. Pain was assessed using a 0-10 numeric rating scale (NRS). A lower score on the NRS indicated less pain and a higher score was indicative of worse pain.
Measured: Study days 5, 7, 10, 13, 17 and 19
Secondary outcomes (3)
Sleep Quality
Medical Outcomes Survey Sleep Quality Subscale. This is a 0-10 numeric rating scale in which patients rate their sleep quality. 0 represents poor sleep quality whereas 10 represents a restful night of sleep.
Measured: 6 weeks after injury timepoint was chosen for this analysis
Itch Symptoms
Average itch intensity measured with a 0-10 numeric rating scale, 6 weeks was used as main outcome timepoint for itch symptom burden. 0 represents no itch symptoms and 10 represents the most severe itch symptoms.
Measured: Week 6 after injury was chosen as the main timepoint of interest
Anxiety Symptoms
Anxiety severity via the State Trait Personality Inventory (STPI), range 10-40, 40 represents high anxiety.
Measured: 6 weeks after injury was chosen as the main timepoint of interest
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2009 (estimated)
- Study startJul 2009
- Primary completionFeb 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for BurnsStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Samuel McLean, MD, MPh, Principal investigator, University of North Carolina, Department of Anesthesiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00934947
- Sponsor's protocol ID
- 09-0681
- Acronym
- BURN HELP
- Status last verified
- Sep 2017
- First submitted
- 6 Jul 2009
- Last updated
- 17 Nov 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The BURN HELP Trial: BURN Healing and AnaLgesia With Propranolol
- ClinicalTrials.gov ID
- NCT00934947
- Acronym / sponsor ID
- BURN HELP / 09-0681
- Keywords
- Burns, Pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Feb 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 8 Jul 2009 (estimated)
- Results
- Posted 29 Oct 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate the ability of propranolol to decrease pain and improve recovery in burn patients with a common genotype.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sugar pill | Placebo comparator | Drug: Placebo |
| Propranolol, Propanolol ER | Experimental | Drug: Propranolol, Drug: Propanolol |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Thermal burn
- Greater than or equal to 18 years of age
- Less than 60 years of age
- Able to speak and read English
Key exclusion criteria (25 listed)
- Intubated
- Clinically unstable
- Other substantial comorbid injury (e.g. long bone fracture)
- Heart block greater than first degree (EKG)
- History of coronary artery disease
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 |
|---|---|---|
| PropranololAlso: Inderal, Innopran40 mg | Drug | Propranolol, Propanolol ER |
| PlaceboAlso: Sugar pillsugar pill | Drug | Sugar pill |
| PropanololAlso: Inderal, Innopran120 mg twice per day | Drug | Propranolol, Propanolol ER |
Primary outcome
Overall Pain Trajectory Slopes
Time frame: Study days 5, 7, 10, 13, 17 and 19
Overall pain trajectory slopes by treatment group, where linear mixed modeling was used to combine pain measurements (waking, worst, and least pain) assessed on primary outcome days into an overall pain score. Pain was assessed using a 0-10 numeric rating scale (NRS). A lower score on the NRS indicated less pain and a higher score was indicative of worse pain.
3 secondary outcomes
Sleep Quality
Time frame: 6 weeks after injury timepoint was chosen for this analysis
Itch Symptoms
Time frame: Week 6 after injury was chosen as the main timepoint of interest
Anxiety Symptoms
Time frame: 6 weeks after injury was chosen as the main timepoint of interest
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- NC Jaycee Burn CenterLink provided by the sponsor.
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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.
Samuel McLean, MD, MPh principal investigator
University of North Carolina, Department of Anesthesiology
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Propranolol and Propanolol in people with Burns and Pain, run by University of North Carolina, Chapel Hill at 4 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 4 inclusion and 25 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 17 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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. Some participants in this study may receive a placebo. 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 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?
Yes. Results are posted in the registry (first posted 29 Oct 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Overall Pain Trajectory Slopes (time frame: Study days 5, 7, 10, 13, 17 and 19). 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 17 Nov 2017.