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

NCT06602271 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 320

Last updated 2026-01-22

No results posted yet for this 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

  • Postoperative Pain, Acute

Interventions

DRUG

PF614 capsule

Experimental oxycodone prodrug

DRUG

Placebo

Inactive medication

Sponsors & Collaborators

  • Rho, Inc.

    collaborator INDUSTRY

  • Ensysce Biosciences

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-09
Primary Completion
2026-08-31
Completion
2026-11-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06602271 on ClinicalTrials.gov