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Palmitoylethanolamide for Tibial Fracture

Phase 2
Waitlist Available
Led By Ariana Nelson, MD
Research Sponsored by University of California, Irvine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months

Summary

This trial is testing whether adding PEA, a natural compound found in foods like peanuts and egg yolks, to standard post-surgery medications can help patients with severe below-knee fractures. The goal is to see if PEA can reduce pain and inflammation, allowing patients to use fewer opioids. PEA works by calming the body's response to injury, which helps with pain and swelling.

Eligible Conditions
  • Broken knee
  • Tibial Fracture
  • Fibula Fracture

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
3 month post-surgical NSAID use Questionnaire
3 month post-surgical Opioid use Questionnaire
Secondary study objectives
Average Pain Interference
Average Pain Scores
Functional Status
+4 more

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: PalmitoylethanolamideActive Control1 Intervention
300 mg PEA twice a day for a total of 600 mg PEA daily 2-month supply upon discharge
Group II: PlaceboPlacebo Group1 Intervention
1 placebo tablet twice a day for a total of 2 tablet placebo daily 2-month supply upon discharge

Find a Location

Who is running the clinical trial?

GE Nutrients Inc. (Gencor)UNKNOWN
University of California, IrvineLead Sponsor
564 Previous Clinical Trials
1,932,616 Total Patients Enrolled
Ariana Nelson, MDPrincipal InvestigatorAssociate Clinical Professor
2 Previous Clinical Trials
150 Total Patients Enrolled
~0 spots leftby Dec 2025
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