A Phase 2 interventional study of Palmitoylethanolamide and Placebo in Tibial Fractures, Fibula Fracture and Knee Fracture, sponsored by University of California, Irvine. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-05-09.
Sponsored by University of California, Irvine · Phase 2, Interventional, and Treatment
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 mechanism in chronic inflammation and chronic pain. In animal and clinical trials, PEA has also shown evidence of pain reduction, sleep improvement, and increased joint mobility and function with minimal side-effects. The study team intends to study whether the inclusion of PEA in conjunction with standard post-surgical medications can reduce pain and inflammation while decreasing the number of opioids needed.
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, 800,000 office visits, and 500,000 hospital days attributed annually. This does not include the approximately 250,000 proximal femur fractures that occur in the US annually, which is expected to double by 2050. There are also over 5 million ankle injuries in the US per year at a rate of approximately 187 ankle fractures per 100,000 people. To repair these below knee fractures, patients with severe cases often have an open reduction and internal fixation (ORIF) surgery to stabilize and heal the broken bone.
On average, these patients are seen by physical therapy to determine their safety for going home and if they need any equipment like a walker or crutches. They are discharged with pain medications, such as analgesic opioids and stool softeners. These patients return to clinic in 2 weeks for follow up which involves an exam, suture removal, x-rays, and possibly weight bearing status update. They then return in 1 month for exam, x-rays, and weightbearing status. Finally they return at 3 months for exam, x-rays, and weightbearing status.
The study team intends to study whether the inclusion of PEA in conjunction with standard post-surgical medications can reduce pain and inflammation while decreasing the number of opioids needed
2,261 studies on the registry are indexed under Fractures, Bone; 325 are open to participants now.
Browse Fractures, Bone studies →University of California, Irvine is the lead sponsor of 466 studies on the registry; 96 are open to participants now.
Of its 41 completed or terminated interventional studies of FDA-regulated products, 30 (73%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
300 mg PEA twice a day for a total of 600 mg PEA daily 2-month supply upon discharge
Drug: Palmitoylethanolamide
1 placebo tablet twice a day for a total of 2 tablet placebo daily 2-month supply upon discharge
Drug: Placebo
2-month supply of PEA will be given upon discharge. 300mg will be taken twice a day in conjunction with discharge medications (opioid and NSAIDs).
Also known as: PEA, GenCor
2-month supply of placebo will be given upon discharge. Placebo will taken twice a day in conjunction with discharge medications (opioid and NSAIDs).
3 month post-surgical Opioid use Questionnaire
Questionnaire (during call) asking patient for list of medications taken in last 2 days and cross referencing with opioid prescription in chart
Time frame: 3 months
3 month post-surgical NSAID use Questionnaire
Questionnaire (during call) asking patient for list of medications taken in last 2 days and cross referencing with NSAID prescription in chart
Time frame: 3 months
Pain Scores
Pain scores using McGill Pain Questionnaire; minimum pain score: 0 (would not be seen in a person with true pain);maximum pain score: 78;The higher the pain score the greater the pain.
Time frame: 3 months
Pain Interference
Pain interference using PROMIS Pain Interference Survey; Each question usually has five response options ranging in value from one to five. To find the total raw score for a short form with all questions answered, sum the values of the response to each question. For example, for the adult 6-item form, the lowest possible raw score is 6; the highest possible raw score is 30.Locate the applicable score conversion table and use this table to translate the total raw score into a T-score for each participant. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10
Time frame: 3 months
Average Pain Scores
Pain scores using Brief Pain Inventory; 0-10 numerical rating scale used to measure three pain severity items: "worst" in the past month, "average," and "now," where 0=no pain and 10=pain as bad as you can imagine.
Time frame: 3 months
Functional Status
Functional status using PROMIS Physical Function Survey; The PF-10a is a 10-item questionnaire assessing current self-reported physical function. Raw scores range from 10 to 50 and can be translated into T-scores, with a mean of 50 and a standard deviation of 10, for comparison with the U.S. general population mean; for this study, all reported PF-10a scores are T-scores.
Time frame: 3 months
Post-Surgical Complications
Any complications following surgery
Time frame: 3 months
Medication Adverse Events
Any adverse events to study drug and post-surgical medications given at discharge
Time frame: 3 months
Average Pain Interference
Pain interference using Brief Pain Inventory; 0-10 numerical rating scale used to measure three pain severity items: "worst" in the past month, "average," and "now," where 0=no pain and 10=pain as bad as you can imagine.
Time frame: 3 months
This study is withdrawn, as verified in May 2023. You cannot join it, but the record below documents what was studied.
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University of California, Irvine