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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
Full 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.
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Inclusion criteria
Inclusion criteria:
Subjects must meet all of the following criteria to be eligible for inclusion into the study:
Exclusion criteria
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.
Primary purpose
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Interventional model
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428 participants in 3 patient groups, including a placebo group
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Central trial contact
Sigal Aviel, PhD
Data sourced from clinicaltrials.gov
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