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

NCT01574131 | Terminated Phase 4 DMC

• 1 other identifier: 11-106
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

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

Second or Third Degree Burns

Keywords

Burn; Fenofibrate; PPAR alpha agonist; insulin sensitivity; mitochondrial

Outcome Measures

Primary Outcomes (1)

• Mitochondrial fatty acid oxygenation

  Changes in mitochondrial oxygen consumption, Palmitoyl-CoA, palmitoyl-L-Carnitine, Pyruvate, Malate, Malonyl-CoA

  6 months post injury

Secondary Outcomes (4)

• Insulin sensitivity

  6month post injury

• Protein Metabolism

  6 months post injury

• Glucose Metabolism

  6 months post injury

• Amino Acid Metabolism

  6 months post injury

Study Arms (2)

Sugar pill

PLACEBO COMPARATOR

pill

Drug: Sugar Pill

Fenofibrate

ACTIVE COMPARATOR

ppar-alpha agonist

Drug: Fenofibrate

Interventions

Fenofibrate DRUG

Pill 54 mg or 160 mg tablets every day for 6 months Dosing-5mg/kg up to 160 mg for 6 months

Also known as: Lofibra

Fenofibrate

Sugar Pill DRUG

pill every day for 6 months

Also known as: Placebo

Sugar pill

Eligibility Criteria

• Age: 4 Years - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

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

Sponsors & Collaborators

• The University of Texas Medical Branch, Galveston: lead
• Shriners Hospitals for Children: collaborator

Study Sites (1)

University of Texas Medical Branch

Galveston, Texas, 77551, United States

Location

MeSH Terms

Conditions

Neoplasm Metastasis; Burns; Insulin Resistance

Interventions

Fenofibrate; Sugars

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Wounds and Injuries; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Fibric Acids; Isobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Phenyl Ethers; Ethers; Benzophenones; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenols; Ketones; Carbohydrates

Study Officials

• David N Herndon, MD

  University of Texas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2012
• First Posted: April 10, 2012
• Study Start: May 1, 2012
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: November 29, 2019

Record last verified: 2016-02

Locations

US (1)