Towards Predicting the Analgesic Response to Ibuprofen Following Third-molar Extraction

• Status: Recruiting
• Trial end date: 2022-04-01
• Target enrollment: 0
• Participant gender: All

Summary

This research study will evaluate inter-individual variability in the analgesic response to the non-steroidal anti-inflammatory drug (NSAID) ibuprofen after third molar extraction surgery. It will also investigate demographic, clinical, genetic, and environmental factors that cause this variability.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Pennsylvania
• Treatments: Acetaminophen; Analgesics; Ibuprofen; Oxycodone

Criteria

Inclusion Criteria:

• 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).

• Body mass index (BMI) between 18 and 30 kg/m2.

• Absence of other major medical problems or contraindications to surgery or study drugs.

• Has not used tobacco products, including smoking cessation nicotine-containing products (e.g., nicotine patch, nicotine gum), for at least the 3 months prior to screening.

• 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. 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)

• In the opinion of the investigators or research coordinators, subjects must be willing and able to understand and comply with study procedures, including completing safety and efficacy diaries at home.

• Able and willing to provide written informed consent prior to any study procedures being performed.

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, performance/attention enhancers, marijuana, anti-depressants). 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 who have taken NSAIDs, including acetaminophen, or other medications for pain, including aspirin or aspirin-containing products within 1 week of study drug administration.

• Subjects who routinely consume high doses of antioxidant vitamins daily (vitamin C > 1000mg, Vitamin E > 400IU, Beta Carotene > 1000IU, Vitamin A > 5000IU, Selenium > 200mcg, Folic Acid > 1mg) during the 2 weeks prior to the start of the study.

• 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 abuse of narcotics, street drugs, prescription sleeping pills, 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.