RecruitingPhase 3NCT06602271

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

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of PF614 for the Treatment of Moderate to Severe Pain After Abdominoplasty


Sponsor

Ensysce Biosciences

Enrollment

320 participants

Start Date

Dec 9, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical trial is to evaluate the analgesic activity of PF614 (an oral oxycodone prodrug extended-release analgesic) for control of postsurgical pain in subjects scheduled for abdominoplasty surgery. The main question to be answered is: • To assess the analgesic efficacy of PF614 compared to placebo in subjects with moderate to severe pain following abdominoplasty. Participants will be asked to take oral blinded doses of study medication at about one hour before surgery starts, and then every 12 hours after surgery for up to 4 days. Participants will be asked to: * Rate their pain on a 0-10 numerical rating scale (NRS) at various timepoints up to 5 days following surgery; * Tell us about the need for rescue medication if they continue to have moderate-to-severe pain; * Tell us about any side effects or adverse effects that they may experience to help us understand the safety and tolerability of the test medications; * Provide periodic blood samples to help us understand how much study drug is in their system. Participants will stay in a clinic setting and be monitored for safety for 5 days following surgery. We anticipate that participants will be discharged on Day 5, pending medical review, and then keep a diary to record study-related pain and adverse effects for an additional 2-4 days after discharge.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called PF614 capsule and a drug called Placebo for people with postoperative pain, acute. The study is currently recruiting participants at 3 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPF614 capsule

Experimental oxycodone prodrug

DRUGPlacebo

Inactive medication


Locations(3)

CenExel / Atlanta Center for Medical Research (ACMR)

Atlanta, Georgia, United States

HD Research - Memorial Hermann Surgery Center

Houston, Texas, United States

CenExel / JBR

Salt Lake City, Utah, United States

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NCT06602271


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