Acute and Long-Term Outcome Investigations of Fenofibrate on Severely Burned Patients

Stopped early · Phase 4 · Has a placebo group

Conditions studied: Second or Third Degree Burns

In brief

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.

Key facts

Study ID

NCT01574131

Run by

The University of Texas Medical Branch, Galveston

People needed

3

Starts

2012-05-01

Expected to finish

2016-02-01

Last updated by the study team

2019-11-29

Who can join

Age: 4 and older, up to 20. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ≥40% Burn
• ages 4-20years
• body weight ≥10kg

You may not qualify if…

• <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

Where it is running

• University of Texas Medical Branch — Galveston, Texas, United States

Full record on ClinicalTrials.gov

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