Variability in Analgesic Response to Ibuprofen

Inclusion criteria

• Provision of signed and dated informed consent form
• Stated willingness to comply with all study procedures and availability for the duration of the study
• Ability to take oral medication and be willing to adhere to the study treatment regimen
• Men and women greater than 18 years of age requiring extraction of at least one impacted mandibular third molar tooth (at least 50% covered with bone).
• Absence of other major medical problems or contraindications to surgery or study drugs.
• Female subjects of child bearing potential must be using a medically acceptable method of contraception (oral contraception, Depo-Provera injection, IUD, condom with spermicide, diaphragm, cervical cap, progestin implant, abstinence, tubal ligation, oophorectomy, TAH) throughout the entire study period. All female subjects must consent to a urine pregnancy test at screening and a urine pregnancy test on the day of surgery, which must be negative at all time points.
• Has not ingested caffeine-containing products within 12 hours of surgery.
• All subjects must consent to a urine drug test at screening. Results must be negative (except for THC) unless the subject is on a stable dose of a non-analgesic drug for a legitimate medical purpose. A positive test for THC will be permitted and the frequency of use will be documented. A positive result will be reported to the subject.
• Does not consume more than 1 alcoholic beverage per day on average.
• Subjects must reach a level of at least moderate pain within four hours of surgery completion, with a pain score greater than or equal to 4 on a 0-10 numerical pain scale
• Subjects must be willing and able to complete safety and efficacy diaries.
• An escort must be available to pick up the subject at the end of at the end of the surgical/dosing visit (Visit #2).

Exclusion criteria

• Female subjects who are pregnant or nursing a child.
• Subjects who have received an investigational drug or used an experimental medical device within 30 days prior to screening, or who gave a blood donation of ≥ one pint within 8 weeks prior to screening.
• Subjects who are sensitive or allergic to ibuprofen, acetaminophen, or their components.
• Subjects who are sensitive or allergic to aspirin or other NSAIDs.
• Subjects who are sensitive or allergic to oxycodone or other opioids (excluding nausea and constipation).
• Presence of a serious medical condition (e.g. poorly controlled hypertension or diabetes, gastrointestinal disorders such as bleeding ulcer, coagulation or bleeding disorders, significantly impaired cardiac, renal, hepatic, respiratory, or thyroid function) that according to the investigator may interfere with interpretation of the study results or compromise the safety of a potential subject.
• Acute local infection at the time of surgery that could confound post-surgical evaluation.
• Use of any confounding prescription or non-prescription drug within 24 hours of the surgical procedure, including analgesics, sedating antihistamine, sedative, alcohol, or CNS/psychotropic agents (i.e. sleep aids, benzodiazepines). Hormonal contraceptives, hormone replacement therapy (including males taking testosterone as a hormone replacement to treat a documented low testosterone level), or thyroid replacement hormones are allowed. Individuals taking other/additional chronic stable medications can be considered on a case-by-case basis for inclusion in the study if agreed upon by judgment of the investigator.
• Subjects with any abnormal laboratory value or physical finding that according to the investigator may interfere with interpretation of the study results, be indicative of an underlying disease state, or compromise the safety of a potential subject.
• Subjects who have a history of opioid use disorder or other substance use disorder, based upon history and judgment of the Investigator.
• Subjects who are unwilling to provide a blood sample for genetic analyses.
• Employees of the principal investigator, sub-investigators, or relative of an employee who is directly involved in this study.