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NCT06602271 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of Postoperative Pain, Acute, sponsored by Ensysce Biosciences.

Recruiting
Registry status
Phase 3
Development phase
320
Enrollment target
3
Study locations

NCT06602271 is a Phase 3 study of Postoperative Pain, Acute that is actively recruiting participants, run by Ensysce Biosciences. The registered enrollment target is 320 participants, above the 167-participant average among 6 other Postoperative Pain, Acute trials with a reported enrollment target (92% higher). The trial reports 3 study locations across 3 states.

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The verdict

NCT06602271, a Phase 3 study of Postoperative Pain, Acute, is actively recruiting participants, sponsored by Ensysce Biosciences.

RECRUITING
Registry status
Phase 3
Development phase
320 participants
Enrollment target
3
Study locations

Study 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.

Conditions Studied

Postoperative Pain, Acute

Interventions

  • DRUG Placebo
  • DRUG PF614 capsule

Study Locations (3)

Georgia

  • CenExel / Atlanta Center for Medical Research (ACMR) - Atlanta

Texas

  • HD Research - Memorial Hermann Surgery Center - Houston

Utah

  • CenExel / JBR - Salt Lake City

Trial Details

FieldValue
Enrollment Target 320 participants
Start Date 2025-12-09
Est. Completion 2026-11
Phase Phase 3

Sponsor

Ensysce Biosciences

9 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06602271

The ClinicalTrials.gov registry entry for NCT06602271 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 320 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 167-participant average among 6 other Postoperative Pain, Acute trials with a reported enrollment target (92% higher). The listed sponsor is Ensysce Biosciences, which has 9 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Postoperative Pain, Acute appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT06602271 reports 3 study locations spanning 3 distinct geographic areas - top geographies include Georgia, Texas, Utah.

Frequently Asked Questions

What is clinical trial NCT06602271 about?

NCT06602271 is a clinical study titled "PF614 Analgesic Activity in Acute Postoperative Pain (PF614-301)". 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 c...

What is the current status of trial NCT06602271?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 320 participants. The study started on 2025-12-09. Estimated completion is 2026-11.

What conditions does trial NCT06602271 study?

This clinical trial studies the following conditions: Postoperative Pain, Acute.

What interventions are being tested in trial NCT06602271?

The interventions under investigation include: Placebo (DRUG), PF614 capsule (DRUG).

Who is sponsoring clinical trial NCT06602271?

This trial is sponsored by Ensysce Biosciences, which has 9 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06602271 being conducted?

This trial has 3 study locations across Georgia, Texas, Utah. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.