Status:
WITHDRAWN
Effect of Palmitoylethanolamide on Reducing Opioid Consumption for Below Knee Fracture Fixation
Lead Sponsor:
University of California, Irvine
Collaborating Sponsors:
GE Nutrients Inc. (Gencor)
Conditions:
Tibial Fractures
Fibula Fracture
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Palmitoylethanolamide (PEA), a non-psychoactive cannabis compound derived from peanuts, egg yolks, and soybeans, is an Endogenous FA Amide produced in the body as a biological response and a repair me...
Detailed Description
According to the National Center for Health Statistics, the United States sees approximately 492,000 tibial fractures per year. Of that population, there are greater than 70,000 hospitalizations, 800,...
Eligibility Criteria
Inclusion
- 18 years of age or older
- Has an isolated below knee orthopaedic injury without any neurovascular injury involvement
- Has an isolated active orthopaedic injury
- Females of childbearing potential must have a negative urine and blood pregnancy test at Screening and a negative urine pregnancy test on Day 1 before study drug is administered. Females must abstain from sex or use a highly effective method of contraception during the period from Screening to administration of study drug and for 30 days after the last dose of study medication. Standard acceptable methods include abstinence or the use of a highly effective method of contraception, including; hormonal contraception, diaphragm, cervical cap, vaginal sponge, condom with spermicide, vasectomy, intrauterine device.
- If females are of non-child bearing potential, they must be post-menopausal defined as: age \> 55 with no menses within the past 12 months or history of hysterectomy, or history of bilateral oophorectomy, or bilateral tubal ligation.
Exclusion
- Less than 18 years of age
- Pregnant or Breastfeeding
- Allergic to cannabis
- History of chronic opioid use
- History of substance abuse
- History of chronic use of cannabis products of any kind
- Has multiple active orthopaedic injuries
- Has neurovascular injury associated with your orthopaedic injury
- History of a syndrome that causes chronic pain (i.e. fibromuscular dysplasia, complex pain syndrome)
- History of peripheral neuropathy
- History of diagnosed psychiatric illness
- ASA score of greater than 3
- Clinically significant unstable medical condition, including but not limited to cardiovascular, neurologic, psychiatric, endocrine, hepatic, and renal disorders.
- Allergy to palmitoylethanolamide (PEA) or its derivatives such as soy or eggs
- AST/ALT ≥3x ULN and/or bilirubin ≥2x ULN at screening.
- Abnormal creatinine or renal function abnormalities.
- Have end stage organ failure (Cardiac, Renal, or Hepatic)
- Currently undergoing addiction/detoxification therapy
Key Trial Info
Start Date :
May 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2025
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT05317676
Start Date
May 1 2023
End Date
December 1 2025
Last Update
May 9 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
UC Irvine Medical Center
Orange, California, United States, 92868