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Palmitoylethanolamide for Knee 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
Awards & highlights

Study Summary

This trial will study whether the inclusion of PEA (a non-psychoactive cannabis compound) in conjunction with standard post-surgical medications can reduce pain and inflammation while decreasing the number of opioids needed.

Eligible Conditions
  • Knee Fracture
  • 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
3 month post-surgical NSAID use Questionnaire
3 month post-surgical Opioid use Questionnaire
Secondary outcome measures
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
545 Previous Clinical Trials
1,923,111 Total Patients Enrolled
Ariana Nelson, MDPrincipal InvestigatorAssociate Clinical Professor
1 Previous Clinical Trials
105 Total Patients Enrolled
~0 spots leftby Dec 2024
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