| Eligibility |
Inclusion Criteria:
- Females have a negative urine pregnancy at screening and on the morning of surgery
- Weight of 100 pounds or greater and have a body mass index (BMI) of 17.5 to 38.0
(inclusive) at screening
- Scheduled to undergo primary, unilateral, distal, first metatarsal bunionectomy
(osteotomy and internal fixation) with no additional collateral procedures.
Participants who have previously undergone bunionectomy on the contralateral foot will
not be prohibited from enrolling in this study if performed greater than or equal to
(>=) 6 months
- Are able to comprehend and follow the requirements of the study (including
pre-surgical instructions provided by the site and availability on scheduled visit
dates) based upon research site personnel's assessment
- Provide written informed consent (for participants who are below the age of legal
consent, parent or legally authorized representative provides written informed consent
and the participant provides written assent)
- Participant agrees to the contraceptive requirements
- Are willing for this to be the only investigational product used during the study
- Have a negative urine drug screen at screening, and on day of surgical procedure. a) a
positive drug screen for a known prescribed concomitant medication that is not
otherwise exclusionary will not disqualify a participant; b) drug and alcohol screen
results must be negative for a participant to receive study medication, a positive
Tetrahydrocannabinol (THC) screen will only be exclusionary on day of surgery (Day 0)
Postoperative Inclusion Criteria
- Participant reports both of the following after discontinuation of the popliteal block
and before 2:00 PM on Day 1. a) moderate or severe pain on a 4-point categorical pain
rating scale (with categories of none, mild, moderate, or severe; b) a score >= 5 on
11-point pain intensity-numerical pain rating scale (PI-NRS)
- Participant is able to answer questions and follow commands, and appropriately
participate in requisite pain evaluation assessments dictated in the protocol
- The surgical procedure from incision to closure was not longer than 2 hours
- The participant has had no evidence of respiratory insufficiency, clinically
significant hypotension, brady cardia, or any other abnormality, during or following
surgery that, in the Investigator's opinion, significantly increases the risks of
study drug administration
- There were no significant deviations from the surgical protocol, anesthetic protocol,
or specified analgesic regimen, that would, in the opinion of the Investigator, put
the participant at risk of participation in the trial, confound the analgesic
endpoints of the trial or cause concern regarding the participants ability to
participate in the trial
Exclusion Criteria:
- Are female and are pregnant, breastfeeding, or currently trying to become pregnant
- Are male with a pregnant partner or a partner who is currently trying to become
pregnant
- Have a known allergy or hypersensitivity to: a) naproxen or other nonsteroidal
anti-inflammatory drugs, including aspirin; b) oxycodone or other opioids; c)
acetaminophen; d) any other drug listed in the surgical and anesthetic protocol or
postoperative pain management of the study protocol
- Have presence or a history of major medical condition that in the investigator's
opinion may jeopardize the participant's safety or well-being, or the integrity of the
study, example; a) hepatic, renal, pancreatic, gastrointestinal, cardiovascular,
cerebrovascular, or thyroid diseases; b) history of head injury or seizures; c)
history of respiratory depression or lung problems such as but not limited to asthma
or chronic obstructive pulmonary disease; d) psychiatric disorders (although
participants with well-controlled depression or anxiety, who are on a stable dose of
medication may be allowed); e) problems urinating; f) history of blockage or narrowing
of the stomach or intestines; g) uncontrolled hypertension indicated as systolic blood
pressure >=160 millimetres of mercury (mmHg) or diastolic blood pressure >=100 mmHg.
Blood pressure may be repeated after the participant has remained in a rested state
for at least 10 minutes. The final blood pressure value will be used for eligibility;
h) uncontrolled diabetes, as determined by the investigator, in the last six months;
i) medical conditions that would interfere with normal pain perception (example
diabetic neuropathy) in the opinion of the Investigator
- Have a history of endoscopically documented peptic ulcer disease or bleeding disorder
in the last two years
- Are not able to swallow whole large tablets or capsules
- Participants will be excluded from the study for any of the following:a) routine use
of oral analgesics >=3 times per week for a medical condition unrelated to bunion pain
in the 2 months prior to surgery; b) opioid tolerant, that is, the participant is
currently taking or has taken a chronic opioid for pain at a dose greater than or
equal to 10 milligrams (mg) hydrocodone per day, more than 1 out of 7 days per week,
in the 2 months prior to surgery; c. History of chronic tranquilizer use, heavy
drinking, opioid abuse, or other substance abuse, as judged by the Investigator, in
the last five years. Heavy drinking is defined as the use of more than four standard
drinks daily or more than 14 drinks a week for men, and more than three standard
drinks daily or more than seven standard drinks in a week for women. Standard drink
refers to 14 grams (g) (0.6 ounce [oz.]) of pure alcohol, which is approximately 12
oz. of beer, 8 oz. of malt liquor, 5 oz. of wine, 1.5 oz. or "shot" of 80 proof
distilled spirits or liquor (example., gin, rum, vodka, or whiskey); d) use of any
immunosuppressive drugs, corticosteroids (except for topical corticosteroids), or
injectable or oral anticoagulants (example., heparin, Lovenox, Xarelto, Eliquis,
Pradaxa, Coumadin, Miradon) within 2 weeks prior to surgery; e) use of monoamine
oxidase inhibitors within 2 weeks prior to surgery; f) use of alcohol within 24 hours
prior to surgery; g) consumption of methylxanthine containing products (example,
chocolate bars or chocolate beverages, coffee, tea, cola or caffeinated energy
drinks), tobacco, or nicotine containing products (example, cigarettes, cigars,
nicotine replacement therapies, vaping devices) less than (<) 12 hours prior to
surgery; h) use of any other over-the-counter or prescription medications or
supplements that, in the Investigator's opinion, may cause participation in the study
to jeopardize the participant's safety or well-being, or may jeopardize the integrity
of the study, within 5 days (or longer if the investigator deems a longer washout is
warranted) prior to surgery
- Have a positive test for human immunodeficiency virus (HIV) antibody, hepatitis B
surface antigen (HBsAg), or hepatitis C virus antibody (anti-HCV)
- Have participated in any interventional clinical trials within 30 days before
screening
- Are related to those persons involved directly or indirectly with the conduct of this
study (that is., Principal Investigator, sub-investigators, study coordinators, other
site personnel, employees of Johnson & Johnson [J&J] subsidiaries, contractors of J&J,
and the families of each)
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