BunionPhase 3NCT05773846
A Study to Evaluate Analgesic Efficacy and Safety of PRF-110 for Post-surgical Pain
A Phase 3 study testing Ropivacaine in people with Bunion, run by PainReform LTD at 7 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bunion
- What is being tested?
- Ropivacaine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 428 participants
- Where
- 7 sitesUnited States
- Study dates
- 13 Mar 2023to 30 Aug 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must meet all of the following criteria to be eligible for inclusion into the study:
- 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.
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- 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.
Who cannot join
- 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.
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- 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%.
- 15. 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.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
First Surgical Hospital 4801 Bissonnet Street
Bellaire, Texas, 77401
Legent Orthopedic Hopital
Carrolton, Texas, 75006
Midwest Clinical Research Center
Dayton, Ohio, 45417
Memorial Hermann Hospital
Houston, Texas, 77043
Woodland International Research Group
Little Rock, Arkansas, 72211
Clinical Pharmacology of Miami
Miami, Florida, 33014
Endeavor Clinical Trials
San Antonio, Texas, 78229
About this study
Official title: 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
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
Read the 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.
- Conditions
- Bunion
- Being tested
- Ropivacaine
- Medical subject headings
- Bunion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RopivacaineDrug
A long acting formulation of ropivacaine
| Study group | Role | What they receive |
|---|---|---|
| PRF-110 | Experimental | PRF-110 3.6% ropivacaine, to be applied into the surgical wound Receives: Drug: Ropivacaine |
| Saline .9% | Placebo comparator | Saline .9%, to b be applied into the surgical wound Receives: Drug: Ropivacaine |
| Ropivacaine | Active comparator | Ropivacaine Hydrochloride 0.5%, up to 10 mL, to be applied into the surgical site Receives: Drug: Ropivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 72 hours
Secondary outcomes (4)
Measurement of patients pain levels of PRF-110 as compared to ropivacaine hydrochloride
Measurement of patients pain levels using an 11-point NRS in order to compare the analgesic efficacy of PRF-110 with ropivacaine hydrochloride (0=no pain and 10=worst pain imaginable) (0.5%) injection administered as an infiltration analgesic during the first 72 hours after completion of bunionectomy surgery.
Measured: 72 hours
Comparison of opiate use to saline placebo
To compare post-surgery opioid consumption (in morphine milligram equivalents) over 72 hours for PRF-110 with that of saline placebo.
Measured: 72 hours
Comparison of opiate use to ropivacaine HCL injection
To compare post-surgery opioid consumption through 72 hours for PRF-110 with that of ropivacaine injection.
Measured: 72 hours
Percentage of opiate free subjects
To compare the percentage of subjects who were opioid free through 72 hours post-surgery for PRF-110 compared with that of ropivacaine injection.
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2023
- Study start13 Mar 2023
- Primary completion30 Jul 2024
- Study completion30 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BunionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study is a randomized, double-blind, placebo and active-controlled study.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 428 participants (actual)
Sponsor and investigators
- Lead sponsor
- PainReform LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Lotus Clinical Research, LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05773846
- Sponsor's protocol ID
- PRF-110-103
- Status last verified
- Dec 2023
- First submitted
- 1 Nov 2022
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05773846
- Acronym / sponsor ID
- PRF-110-103
- Conditions
- Bunion
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 428 participants (actual)
- Lead sponsor
- PainReform LTDIndustry (pharma, biotech, devices)
- Collaborators
- Lotus Clinical Research, LLC
- Study start
- 13 Mar 2023 (actual)
- Primary completion
- 30 Jul 2024 (actual)
- Study completion
- 30 Aug 2024 (actual)
- First posted
- 17 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- The study is a randomized, double-blind, placebo and active-controlled study.
| Arm | Type | Receives |
|---|---|---|
| PRF-110 | Experimental | Drug: RopivacainePRF-110 3.6% ropivacaine, to be applied into the surgical wound |
| Saline .9% | Placebo comparator | Drug: RopivacaineSaline .9%, to b be applied into the surgical wound |
| Ropivacaine | Active comparator | Drug: RopivacaineRopivacaine Hydrochloride 0.5%, up to 10 mL, to be applied into the surgical site |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Subjects must meet all of the following criteria to be eligible for inclusion into the study:
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RopivacaineA long acting formulation of ropivacaine | Drug | PRF-110, Ropivacaine, Saline .9% |
Primary outcome
Measurement of patients pain levels as an indication for the analgesic efficacy of PRF-110
Time frame: 72 hours
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)
4 secondary outcomes
Measurement of patients pain levels of PRF-110 as compared to ropivacaine hydrochloride
Time frame: 72 hours
Comparison of opiate use to saline placebo
Time frame: 72 hours
Comparison of opiate use to ropivacaine HCL injection
Time frame: 72 hours
Percentage of opiate free subjects
Time frame: 72 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ropivacaine in people with Bunion, run by PainReform LTD at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of patients pain levels as an indication for the analgesic efficacy of PRF-110 (time frame: 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.