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A Study to Evaluate Analgesic Efficacy and Safety of PRF-110 for Post-surgical Pain | Clinical Trials | Clareo Health

COMPLETEDPHASE3

A Study to Evaluate Analgesic Efficacy and Safety of PRF-110 for Post-surgical Pain

A Phase 3, Randomized, Double-Blind, Saline Placebo- and Active-Controlled, Multicenter Study to Evaluate the Analgesic Efficacy and Safety of Intra-operative Administration of PRF-110 Following Unilateral Bunionectomy

NCT05773846•PainReform LTD

View on ClinicalTrials.gov

Summary

PRF-110 is a viscous, yellowish clear oily solution of ropivacaine intended for administration into surgical sites to provide post-operative analgesia. The pharmacokinetic profile for PRF-110 suggests that its effect could last up to 72 hours. This is A Phase 3, Randomized, Double-Blind, Saline Placebo- and Active-Controlled, Multicenter Study to Evaluate the Analgesic Efficacy and Safety of Intra-operative Administration of PRF-110 Following Unilateral Bunionectomy

Detailed Description

PRF-110 is a unique, sustained-release, oil-based solution formulation of ropivacaine intended for administration into surgical sites for the prevention of postoperative pain. The formulation is designed to have an effect for up to 72 hours. It is postulated that PRF-110 will improve postoperative pain management by providing prolonged pain relief at the surgical site; thereby, reducing the amount of systemic analgesia needed after surgery. The slow, local release of ropivacaine following administration of PRF-110 has been demonstrated in dissolution studies, in postoperative pain studies in animals, in an experimental pain study in human volunteers, and in an open-label Phase 2 hernia repair trial to result in very low plasma concentrations of drug, therefore reducing the probability of systemic adverse events. This is a randomized, double-blind study to evaluate the efficacy and safety of PRF-110 compared with saline placebo and with ropivacaine hydrochloride injection administered intraoperatively in subjects undergoing unilateral bunionectomy.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Subjects must meet all of the following criteria to be eligible for inclusion into the study:
•1. Able to provide written informed consent prior to any study procedures.
•2. Able to communicate clearly with the Investigators and study staff.
•3. Males and females aged 18 years or older.
•4. Scheduled for elective primary unilateral first metatarsal bunionectomy surgery (osteotomy and internal fixation) with no ancillary procedures.
•5. Female subjects must be surgically sterile; or at least 2 years postmenopausal; or have a monogamous partner who is surgically sterile; or practicing doublebarrier contraception; or practicing abstinence (must agree to use double-barrier contraception in the event of sexual activity); or using an insertable, injectable, transdermal, or combination oral contraceptive approved by the FDA for greater than two months prior to screening and commit to the use of an acceptable form of birth control for the duration of the study and for 30 days after completion of the study.
•6. Negative alcohol breath/saliva test and urine drug screen for drugs of abuse at Screening and at Baseline. Subjects with positive results on the alcohol breath/saliva test or urine drug screen at Screening, and/or prior to surgery, will not be allowed to proceed in the study unless the results can be explained by a current prescription or acceptable over-the-counter medication as determined by the Investigator. Note that for those subjects who test positive for tetrahydrocannabinol (THC), if they are willing to abstain from use or consumption of THC-containing products from Screening thru last Follow-up Visit, they may be allowed to participate in the study.
•7. American Society of Anesthesiologists (ASA) Physical Status of I or II (see Appendix, Section 14.1).
•8. Body Mass Index (BMI) ≤35.

Exclusion Criteria

•subject will be excluded from the study if any of the following criteria are met:
•1. Has clinically significant allergies to an opioid, unless has subsequently tolerated other opioids and, in the opinion of the Investigator, could tolerate a rescue drug containing oxycodone.
•2. Has a known or suspected allergy to any local anesthetic or to acetaminophen.
•3. Has a known or suspected history of alcohol, opiate or other drug abuse or dependence within 12 months prior to screening.
•4. Is unable to refrain from alcohol consumption for a period beginning 24 hours prior to surgery through the end of the 72 -hour evaluation period.
•5. Has taken any analgesic or non-opioid pain medication other than acetaminophen (e.g., NSAIDs, cyclooxygenase-2 \[COX 2\] inhibitors) within 12 hours prior to surgery or any aspirin-containing product within 7 days of the Baseline assessments. Aspirin up to 325 mg once daily for cardiovascular prophylaxis is allowed.
•6. Has taken any opioid analgesics or used systemic steroids within 4 days of surgery.
•7. Has been using opiates or any non-steroidal anti-inflammatory drug chronically (more than 10 consecutive days) anytime over the past 3 months.
•8. Has used antipsychotics or antiepileptics within 30 days prior to surgery. Use of sedatives, hypnotics, antianxiety agents, and antidepressants (other than monoamine oxidase inhibitors \[MAOIs\]) are allowed if being used for a nonpain indication and at a stable dose within the previous 30 days.
•9. Has history of or positive test results for HIV or hepatitis B or C at Screening.
+5 more criteria

Locations (7)

Woodland International Research Group

Little Rock, Arkansas, United States

Clinical Pharmacology of Miami

Miami, Florida, United States

Midwest Clinical Research Center

Dayton, Ohio, United States

First Surgical Hospital 4801 Bissonnet Street

Bellaire, Texas, United States

Legent Orthopedic Hopital

Carrolton, Texas, United States

Memorial Hermann Hospital

Houston, Texas, United States

Endeavor Clinical Trials

San Antonio, Texas, United States

Key Dates

Start Date

March 13, 2023

Primary Completion Date

July 30, 2024

Completion Date

August 30, 2024

Last Updated

September 19, 2024

Enrollment

428

ACTUAL participants

Conditions

Bunion

Interventions

Ropivacaine

DRUG

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COMPLETEDNA

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WITHDRAWN

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 19, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study to Evaluate Analgesic Efficacy and Safety of PRF-110 for Post-surgical Pain

Inclusion Criteria

Exclusion Criteria

LSTR in Chevron Osteotomy

Ultrasound-Guided Percutaneous Peripheral Nerve Stimulation: A Department of Defense Funded Pragmatic Clinical Trial

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