Clinical trial · Interventional
Acute and Long-Term Outcome Investigations of Fenofibrate on Severely Burned Patients
NCT01574131CI-TRIAL-00041988terminatedPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): lost funding; Shriner Burn Hosp has revoked access to study records. No updates or results can be submitted
Summary
Brief summary (as posted)
The purpose of this study is to learn the following: whether long-term treatment (6 months) with fenofibrate will decrease burn related sugar and fat increased in the blood and help prevent muscle loss and improve wound healing.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Second or Third Degree Burns | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fenofibrate | Drug | — | UNRESOLVED |
| Sugar Pill | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- PLACEBO_COMPARATOR
- label
- Sugar pill
- description
- pill
- interventionNames
- Drug: Sugar Pill
- type
- ACTIVE_COMPARATOR
- label
- Fenofibrate
- description
- ppar-alpha agonist
- interventionNames
- Drug: Fenofibrate
Primary outcomes (1)
- measure
- Mitochondrial fatty acid oxygenation
- timeFrame
- 6 months post injury
- description
- Changes in mitochondrial oxygen consumption, Palmitoyl-CoA, palmitoyl-L-Carnitine, Pyruvate, Malate, Malonyl-CoA
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 4 Years
- Maximum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: * ≥40% Burn * ages 4-20years * body weight ≥10kg Exclusion Criteria: * \<40% burn * ages \<4-\>20 years * body weight \<10kg * Respiratory insufficiency * Multiple fractures * History of cancer in last 5 years * Bilirubin\>3mg/dL * Serum Creatinine\>3mg/dL after fluid resuscitation * Glutamyl-Oxaloacetic Transaminase(GOT) \>40 Units/L * Glutamyl-Pyruvate Transminase(GPT) \>51 Units/L * Associated head injuries requiring therapy * Associated injuries to the chest or abdomen requiring surgery * Receipt of any experimental drug other than the ones supplied within two months of study * Any metal in body including rods, cardiac defibrillators, pacemaker, etc * Orthopedic casting which would prevent placement in MRI * Hepatitis * Abnormal EKG * Electrical burns
References
Publications (0)
Data not yet available
No reference posted for this study.