BurnPhase 2/3NCT02452255
Fenofibrate and Propranolol in Burn Patients
A Phase 2/3 study testing Fenofibrate and Propranolol in people with Burn, run by The University of Texas Medical Branch, Galveston at 1 site in United States.
Trial summary
The proposed study will test the hypothesis that Propranolol, fenofibrate and fenofibrate plus propranolol have therapeutic, physiological, and metabolic effects that will improve clinical outcomes, and the long-term recovery, rehabilitation, and QOL in burned patients. Read more about this study
- Who is it for?
- Ages Up to 80 years
- Conditions the study is for
- Burn
- What is being tested?
- Fenofibrate and Propranolol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2015to 12 Jul 2019
- Phase
- Phase 2/3
- 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 Up to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 0 through 80 years
- ≥ 20% Total Body Surface Area Burn injury
Who cannot join
- Pregnancy
- History or existence of pre-burn injury conditions
- Allergies to propranolol or fenofibrate
- Asthma requiring treatment
- Congestive heart failure (measured ejection fraction < 20%)
- Renal or hepatic disease
Show all 10Show fewer
- Medical condition requiring glucocorticoid treatment
- History of AIDS, Aids Related Complex or HIV
- History of Cancer within 5 years
- Decision not to treat due to burn injury severity or futility as deemed by the clinical team
Trial locations and contacts
1 site in 1 country.
United States1 site
Shriners Hospitals for Children
Galveston, Texas, 77551
About this study
Official title: Mechanisms of Fenofibrate and Propranolol Alone or Combined in Burn Patients
The proposed study will test the hypothesis that Propranolol, fenofibrate and fenofibrate plus propranolol have therapeutic, physiological, and metabolic effects that will improve clinical outcomes, and the long-term recovery, rehabilitation, and QOL in burned patients.
Read the detailed description
Determine the clinical benefits and underlying mechanisms whereby the metabolic perturbators fenofibrate and propranolol impact burn patient outcomes. The investigators hypothesize that these metabolic regulators given for one year will maintain body mass, improve muscle function by increasing protein synthesis, augment wound healing, reduce fibrosis, improve cardiovascular function, reduce systemic inflammation, restore insulin sensitivity, and decrease liver dysfunction without the risk of the hypoglycemia.
- Conditions
- Burn
- Being tested
- Fenofibrate, Placebo, Propranolol
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FenofibrateDrug
Also called Tricor
Fenofibrate by mouth given daily throughout hospitalization for up to 12 months
PlaceboDrug
Also called Control
Placebo by mouth given daily throughout hospitalization for up to 12 months
PropranololDrug
Also called Metoprolol, inderal
Propranolol by mouth given daily throughout hospitalization for up to 12 months
| Study group | Role | What they receive |
|---|---|---|
| Fenofibrate | Active comparator | Fenofibrate by mouth given daily throughout hospitalization for up to 12 months Receives: Drug: Fenofibrate |
| Fenofibrate and Propranolol | Active comparator | Fenofibrate and Propranolol by mouth given throughout hospitalization for up to 12 months Receives: Drug: Fenofibrate; Drug: Propranolol |
| Placebo | Placebo comparator | Placebo by mouth given daily throughout hospitalization for up to 12 months. Receives: Drug: Placebo |
| Propranolol | Active comparator | Propranolol by mouth given throughout hospitalization for up to 12 months Receives: Drug: Propranolol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose Metabolism
Glucose levels and amount of regular insulin infused during hospitalization.
Measured: From randomization up to one year
Secondary outcomes (2)
Hypermetabolism
Resting energy expenditure (REE) done weekly while in hospital
Measured: From randomization up to one year
Rate pressure product
Multiply the subjects resting heart rate and systolic blood pressure measurements and average every 24 hours while hospitalized
Measured: Participants will be followed for the duration of hospital stay, an average of 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2015 (estimated)
- Study startNov 2015
- Primary completionDec 2018
- Study completion12 Jul 2019
Why it stopped: Shriner's Burn Hospital closed the study and access to study-related data is unavailable. We are unable to submit the additional information or results-data
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BurnStudies of the same condition, open and under way.
- More trials run by The University of Texas Medical Branch, GalvestonThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS), Shriners Hospitals for Children
- Responsible party
- Sponsor
- Investigators
- David N Herndon, MD, Principal investigator, University of Texas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02452255
- Sponsor's protocol ID
- 14-0441
- Other IDs
- NIH RO1GM056687
- Status last verified
- Aug 2018
- First submitted
- 12 May 2015
- Last updated
- 29 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanisms of Fenofibrate and Propranolol Alone or Combined in Burn Patients
- ClinicalTrials.gov ID
- NCT02452255
- Acronym / sponsor ID
- 14-0441
- Conditions
- Burn
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Shriner's Burn Hospital closed the study and access to study-related data is unavailable. We are unable to submit the additional information or results-data
- Enrolment
- 18 participants (actual)
- Lead sponsor
- The University of Texas Medical Branch, GalvestonUniversity, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS), Shriners Hospitals for Children
- Study start
- Nov 2015
- Primary completion
- Dec 2018 (actual)
- Study completion
- 12 Jul 2019 (actual)
- First posted
- 22 May 2015 (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.
The proposed study will test the hypothesis that Propranolol, fenofibrate and fenofibrate plus propranolol have therapeutic, physiological, and metabolic effects that will improve clinical outcomes, and the long-term recovery, rehabilitation, and QOL in burned patients.
Detailed description
Determine the clinical benefits and underlying mechanisms whereby the metabolic perturbators fenofibrate and propranolol impact burn patient outcomes. The investigators hypothesize that these metabolic regulators given for one year will maintain body mass, improve muscle function by increasing protein synthesis, augment wound healing, reduce fibrosis, improve cardiovascular function, reduce systemic inflammation, restore insulin sensitivity, and decrease liver dysfunction without the risk of the hypoglycemia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Fenofibrate | Active comparator | Drug: FenofibrateFenofibrate by mouth given daily throughout hospitalization for up to 12 months |
| Fenofibrate and Propranolol | Active comparator | Drug: Fenofibrate, Drug: PropranololFenofibrate and Propranolol by mouth given throughout hospitalization for up to 12 months |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo by mouth given daily throughout hospitalization for up to 12 months. |
| Propranolol | Active comparator | Drug: PropranololPropranolol by mouth given throughout hospitalization for up to 12 months |
Who may qualify
- Ages
- Up to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 0 through 80 years
- ≥ 20% Total Body Surface Area Burn injury
Key exclusion criteria (10 listed)
- Pregnancy
- History or existence of pre-burn injury conditions
- Allergies to propranolol or fenofibrate
- Asthma requiring treatment
- Congestive heart failure (measured ejection fraction < 20%)
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 |
|---|---|---|
| FenofibrateAlso: TricorFenofibrate by mouth given daily throughout hospitalization for up to 12 months | Drug | Fenofibrate, Fenofibrate and Propranolol |
| PlaceboAlso: ControlPlacebo by mouth given daily throughout hospitalization for up to 12 months | Drug | Placebo |
| PropranololAlso: Metoprolol, inderalPropranolol by mouth given daily throughout hospitalization for up to 12 months | Drug | Fenofibrate and Propranolol, Propranolol |
Primary outcome
Glucose Metabolism
Time frame: From randomization up to one year
Glucose levels and amount of regular insulin infused during hospitalization.
2 secondary outcomes
Hypermetabolism
Time frame: From randomization up to one year
Rate pressure product
Time frame: Participants will be followed for the duration of hospital stay, an average of 5 weeks
Results and safety
The study was stopped early (reason given: Shriner's Burn Hospital closed the study and access to study-related data is unavailable. We are unable to submit the additional information or results-data). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2019.
- Individual participant dataSharing planned: No
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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.
David N Herndon, MD principal investigator
University of Texas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Fenofibrate and Propranolol in people with Burn, run by The University of Texas Medical Branch, Galveston at 1 site 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 2 inclusion and 10 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: stopped early, as of the sponsor's last update on 29 Nov 2019. 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 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was stopped early (reason given: Shriner's Burn Hospital closed the study and access to study-related data is unavailable. We are unable to submit the additional information or results-data). Results are not available in the source record.
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?
Glucose Metabolism (time frame: From randomization up to one year). 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 29 Nov 2019; AzTrials last refreshed its copy on 4 Nov 2026.