PF614 for Acute Postoperative Pain after Abdominoplasty

This study is testing PF614, an experimental oxycodone prodrug, to see how well it manages moderate to severe pain after abdominoplasty (tummy tuck) surgery. You could join if you are between 18 and 75 years old and are scheduled for this type of surgery. The study will compare PF614 to a placebo (an inactive medication) to see if PF614 helps reduce pain more effectively over 48 hours after surgery. The study aims to enroll 320 participants, but its current recruitment status is unclear.

Study design
This is a Phase 3, randomized, double-blind, placebo-controlled study involving 320 participants. Participants will be assigned to one of four treatment groups, receiving either different doses of PF614 or a placebo.
What's involved
You would take study medication before surgery and every 12 hours for up to 4 days. You would also rate your pain on a scale for up to 5 days after surgery and stay at the study center for 5 days and 4 nights.
Compensation
Not stated in the trial record.
Follow-up
You will be followed for pain ratings for up to 5 days after surgery.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06602271

PF614 Analgesic Activity in Acute Postoperative Pain (PF614-301)

Recruiting
PHASE3Ages 18–75InterventionalTreatment
Ensysce Biosciences
~320 participants
Updated 2026-01-22 on ClinicalTrials.gov
What's tested:PF614 capsulePlacebo

At a glance

Recruiting sites
3 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Pain NRS-R area under the curve through 48 hours (AUC4-48)
Measured over 4-48 hours
Postoperative Pain, Acute
3 sites across 3 states
Georgia1
Texas1
Utah1

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  • Pain NRS-R area under the curve through 48 hours (AUC4-48)4-48 hours

    Pain at rest