Your session is about to expire
← Back to Search
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 72 hours
Awards & highlights
Study Summary
This trial will evaluate a new pain relief drug to provide 72 hours of post-op pain relief after bunionectomy.
Who is the study for?
Adults over 18 scheduled for bunion surgery who can consent and communicate with the study team. Women must use effective birth control or be non-fertile. Participants need a BMI ≤35, no drug/alcohol abuse, not on certain medications like opiates or NSAIDs recently, and have good organ function.Check my eligibility
What is being tested?
The trial is testing PRF-110, an extended-release ropivacaine solution for pain relief after bunion surgery. It's compared to a placebo and another painkiller in a double-blind setup where neither doctors nor patients know who gets which treatment.See study design
What are the potential side effects?
Ropivacaine may cause side effects such as low blood pressure, nausea, vomiting, dizziness, numbness around the mouth, tingling sensations or ringing in the ears. Severe reactions are rare but could include seizures or heart problems.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 72 hours
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~72 hours
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Measurement of patients pain levels as an indication for the analgesic efficacy of PRF-110
Secondary outcome measures
Comparison of opiate use to ropivacaine HCL injection
Comparison of opiate use to saline placebo
Measurement of patients pain levels of PRF-110 as compared to ropivacaine hydrochloride
+1 moreTrial Design
3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: PRF-110Experimental Treatment1 Intervention
PRF-110 3.6% ropivacaine, to be applied into the surgical wound
Group II: RopivacaineActive Control1 Intervention
Ropivacaine Hydrochloride 0.5%, up to 10 mL, to be applied into the surgical site
Group III: Saline .9%Placebo Group1 Intervention
Saline .9%, to b be applied into the surgical wound
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ropivacaine
2017
Completed Phase 4
~1960
Find a Location
Who is running the clinical trial?
PainReform LTDLead Sponsor
3 Previous Clinical Trials
45 Total Patients Enrolled
Lotus Clinical Research, LLCOTHER
14 Previous Clinical Trials
1,350 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:Research Study Groups:
This trial has the following groups:- Group 1: PRF-110
- Group 2: Saline .9%
- Group 3: Ropivacaine
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What adverse effects could be experienced when ingesting PRF-110?
"Our research team at Power assigned PRF-110 a score of 3 due to the existence of numerous studies and data sets proving its efficacy and safety in this Phase 3 trial."
Answered by AI
Who else is applying?
What site did they apply to?
Woodland International Research Group
What portion of applicants met pre-screening criteria?
Met criteria
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger