AI-Powered Research

1. Males and females 16 years to 40 years of age (inclusive).
2. Outpatients who have moderate to severe post-operative pain (confirmed by a Visual Analog Scale Pain Severity Rating Scale (VAS-PSR) score of at least 50 mm on a 100-mm VAS-PSR) following surgical extraction of two or more third molars, at least one of which must be a partial or complete bony mandibular impaction.
3. Use of only the following pre-operative medication(s)/anesthetic(s): topical benzocaine, a short-acting parenteral (local) anesthetic (mepivacaine or lidocaine) with or without vasoconstrictor and/or nitrous oxide.
4. Examined by the attending dentist or physician and medically cleared to participate in the study.
5. In general good health and have no contraindications to the study or rescue medication.
6. Reliable, cooperative, and of adequate intelligence to record the requested information on the analgesic questionnaire form.
7. Subjects (or the parent or legal guardian of subjects under the age of 18 years) are required to read, comprehend, and sign the informed consent. Subjects requiring a parent or legal guardian to sign the informed consent form will also be required to sign an assent.
Are the trial subjects under 18? yes
Number of subjects for this age range: 111
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 205
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

1.Presence or history of any significant hepatic, renal, endocrine, cardiovascular, neurological, psychiatric, gastrointestinal, pulmonary, hematologic, or metabolic disorder determined by the Principal Investigator to place the subject at increased risk.
2.Use of a prescription or over-the-counter (OTC) drug with which administration of ibuprofen or any other non-steroidal anti-inflammatory drug (NSAID), acetaminophen (APAP), or hydrocodone is contraindicated (including: opioids, antipsychotics, antianxiety agents, or other central nervous system depressants [including alcohol]).
3. Use of prescription or OTC antihistamines within 24 hours prior to taking study medication. (Note exceptions: loratadine [Claritin], desloratadine [Clarinex], cetirizine [Zyrtec ], levocetirizine [Xyzal], fexofendadine [Allegra], and azelastine [Intranasal, Astelin]).
4. Use of a bisphosphonate (e.g., pamidronate [Aredia], risedronate [Actonel], alendronate [Fosamax], or ibandronate [Boniva]) in the past 5-years.
5. Acute localized dental alveolar infection at the time of surgery that could confound the post-surgical evaluation.
6. Female subjects who are pregnant, lactating, of child-bearing potential or post-menopausal for less than 2 years and not using a medically approved method of contraception (i.e., oral, transdermal, or implanted contraceptives, intrauterine or intravaginal device [IUD or NuvaRing ], diaphragm, condom, abstinence, or surgical sterility including partner’s vasectomy), or who test positive on a urine-based pregnancy test.
7. Presence or history (within 2 years of enrollment) of gastrointestinal ulcer or gastrointestinal bleeding.
8. Presence or history (within 2 years of enrollment) of a bleeding disorder.
9. Presence or history of alcohol (3 or more alcoholic drinks per day on a regular basis) or substance abuse within 2 years of enrollment (note: one drink of alcohol is 1 oz. liquor, 6 oz. wine, or 12 oz. beer) or currently abusing other mood-altering drugs (e.g., cannabis). Patients who are taking St. John’s Wort, or any other nutritional supplement known to have psychotropic effects may be enrolled if they have been on stable doses of medication for at least 2 months, will maintain this dose throughout the study, and their condition is judged by the Principal Investigator to be well-controlled.
10. Habituation to analgesic medications (i.e., routine use of oral analgesics 5 or more times per week).
11. Hypersensitivity to ibuprofen, naproxen, aspirin, or any other NSAID; or to APAP, hydrocodone, other opioids, or to their combinations.
12. Prior use of any type of analgesic or Non-Steroidal Anti Inflammatory Drug (NSAID) within five half-lives of that drug or less before taking the first dose of study medication, except for pre-anesthetic medication and anesthesia for the procedure.
13. Currently taking a monoamine oxidase inhibitor (MAOI), antipsychotic, or any other neuroleptic or has taken:
•A MAOI within 2 months of screening (Note: subjects may not discontinue taking an MAOI solely for the purpose of qualifying for the study)
•An antipsychotic or other neuroleptic within 14 days of surgery (Note: subjects may not discontinue taking these medications solely for the purpose of qualifying for the study)
14. Patients who are

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the efficacy of a single-dose of a novel ibuprofen formulation, ibuprofen sodium tablets (IBU Na; 2 x 256 mg [equivalent to 400 mg ibuprofen]) in the third molar extraction model of dental pain compared to a single-dose of 1) Advil Tablets, (standard ibuprofen; 2 x 200 mg), 2) Motrin IB (standard ibuprofen; 2 x 200 mg), and 3) placebo.;Secondary Objective: Not Applicable;Primary end point(s): Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference From 0-8 Hours (SPRID 0-8)<br><br>Time to Onset of Meaningful Relief<br>0 to 8 hours ;Timepoint(s) of evaluation of this end point: 0 to 8 hours<br> <br>0 to 8 hours

Secondary Outcome Measures