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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: Recruiting Phase 3 study of Postoperative Pain, Acute, sponsored by Ensysce Biosciences.
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 160-participant average among 7 other Postoperative Pain, Acute trials with a reported enrollment target (100% higher). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Pain at rest
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 320 participants |
| Start Date | 2025-12-09 |
| Est. Completion | 2026-11 |
| Phase | Phase 3 |
What NCT06602271 shows while recruiting
NCT06602271 is an interventional study that assigns participants to a tested intervention. The registered 320 participants enrollment target is mid-sized for trials with a published cap, above the 160-participant average among 7 other Postoperative Pain, Acute trials with a reported enrollment target (100% higher).
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 a single indexed study location in 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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