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

NCT05773846 | Completed Phase 3 FDA Drug

• 1 other identifier: PRF-110-103
• Study Type: interventional
• Target: 428
• Locations: 1 country
• Sites: 7

Brief 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

Conditions

Bunion

Outcome Measures

Primary Outcomes (1)

• Measurement of patients pain levels as an indication for the analgesic efficacy of PRF-110

  The primary objective of this study is to compare the analgesic efficacy of PRF-110 with placebo during the first 72 hours after completion of bunionectomy surgery by measuring pain levels using an 11-point Numerical Rating Scale (NRS)

  72 hours

Secondary Outcomes (4)

• Measurement of patients pain levels of PRF-110 as compared to ropivacaine hydrochloride

  72 hours

• Comparison of opiate use to saline placebo

  72 hours

• Comparison of opiate use to ropivacaine HCL injection

  72 hours

• Percentage of opiate free subjects

  72 hours

Study Arms (3)

PRF-110

EXPERIMENTAL

PRF-110 3.6% ropivacaine, to be applied into the surgical wound

Drug: Ropivacaine

Saline .9%

PLACEBO COMPARATOR

Saline .9%, to b be applied into the surgical wound

Drug: Ropivacaine

Ropivacaine

ACTIVE COMPARATOR

Ropivacaine Hydrochloride 0.5%, up to 10 mL, to be applied into the surgical site

Drug: Ropivacaine

Interventions

Ropivacaine DRUG

A long acting formulation of ropivacaine

PRF-110; Ropivacaine; Saline .9%

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to provide written informed consent prior to any study procedures.
• Able to communicate clearly with the Investigators and study staff.
• Males and females aged 18 years or older.
• Scheduled for elective primary unilateral first metatarsal bunionectomy surgery (osteotomy and internal fixation) with no ancillary procedures.
• 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.
• 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.
• American Society of Anesthesiologists (ASA) Physical Status of I or II (see Appendix, Section 14.1).
• Body Mass Index (BMI) ≤35.

You may not qualify if:

• subject will be excluded from the study if any of the following criteria are met:
• 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.
• Has a known or suspected allergy to any local anesthetic or to acetaminophen.
• Has a known or suspected history of alcohol, opiate or other drug abuse or dependence within 12 months prior to screening.
• 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.
• 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.
• Has taken any opioid analgesics or used systemic steroids within 4 days of surgery.
• Has been using opiates or any non-steroidal anti-inflammatory drug chronically (more than 10 consecutive days) anytime over the past 3 months.
• 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.
• Has history of or positive test results for HIV or hepatitis B or C at Screening.
• Has any history of epilepsy, other than childhood febrile seizures, before the age of 6.
• Has any history of psychosis, current clinically significant symptomatic psychiatric disorder, or a history of suicide attempt in the past 10 years.
• Has taken herbal agents or nutraceuticals (e.g., chapparal, comfrey, germander, jin bu huan, kava, pennyroyal, skullcap, St. John's wort, or valerian) during any of the 7 days prior to surgery that could potentially confound the analgesic response in the Investigator's opinion.
• Has transaminase levels \> 2 x ULN, or bilirubin level \> 1.5 x ULN (unless Gilbert's syndrome), or estimated glomerular filtration rate (eGFR) \< 60 mL/min. Has poorly controlled diabetes with hemoglobin A1c \>7.5%.
• \. Has any clinically significant condition including an acute or chronic painful physical restrictive condition or any other significant laboratory abnormality that would, in the opinion of the Investigator, confound study assessments or adversely affect subject safety. 16. Has received another investigational drug within 30 days of scheduled surgery.

Sponsors & Collaborators

• PainReform LTD: lead
• Lotus Clinical Research, LLC: collaborator

Study Sites (7)

Woodland International Research Group

Little Rock, Arkansas, 72211, United States

Location

Clinical Pharmacology of Miami

Miami, Florida, 33014, United States

Location

Midwest Clinical Research Center

Dayton, Ohio, 45417, United States

Location

First Surgical Hospital 4801 Bissonnet Street

Bellaire, Texas, 77401, United States

Location

Legent Orthopedic Hopital

Carrolton, Texas, 75006, United States

Location

Memorial Hermann Hospital

Houston, Texas, 77043, United States

Location

Endeavor Clinical Trials

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Bunion

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

Foot Deformities, Acquired; Foot Deformities; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Before the start of the study, a computer-generated randomization schedule will be prepared for each site. The randomization codes will be stored in a secured area. Uniquely numbered study medication kits will be assigned to subjects according to the randomization codes. Randomization will take place on the day of surgery (Day 1) after performance of baseline assessments. Subjects who continue to meet eligibility criteria will be randomized in a 2:2:1 ratio to 1 of the 3 treatment groups:
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The study is a randomized, double-blind, placebo and active-controlled study.

Study Record Dates

• First Submitted: November 1, 2022
• First Posted: March 17, 2023
• Study Start: March 13, 2023
• Primary Completion: July 30, 2024
• Study Completion: August 30, 2024
• Last Updated: September 19, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)