A Study to Evaluate Analgesic Efficacy and Safety of PRF-110 for Post-surgical Pain (NCT05773846) | Clinical Trial Compass
CompletedPhase 3
A Study to Evaluate Analgesic Efficacy and Safety of PRF-110 for Post-surgical Pain
United States428 participantsStarted 2023-03-13
Plain-language 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
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Measurement of patients pain levels as an indication for the analgesic efficacy of PRF-110
. 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.
Exclusion criteria
. 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.