A Safety And Efficacy Study of Ibuprofen 250 mg / Acetaminophen 500 mg In The Treatment Of Post-Surgical Dental Pain
Condition: Post-surgical Pain Following Extraction of Molar Teeth
MeSH terms: Pain, Postoperative
Intervention: Ibuprofen 250 mg / Acetaminophen 500 mg; Ibuprofen 250 mg; Acetaminophen 650 mg; Placebo
Intervention description: 2 caplets of Ibuprofen 250 mg / Acetaminophen 500 mg; 2 caplets of Ibuprofen 125 mg; 2 tablets of Acetaminophen 325 mg; 2 caplets of Placebo
Intervention MeSH terms: Acetaminophen; Ibuprofen
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 568.0
Sex: All
Minimum age: 18 Years
Maximum age: 40 Years
Healthy volunteers: No
Keywords: ibuprofen; acetaminophen; pain; molar extraction

Summary:

      This is a randomized, double blind, placebo-controlled, parallel group, single-center study
      in approximately 560 subjects to determine the overall analgesic efficacy and safety of a
      fixed-dose ibuprofen 250 mg / acetaminophen 500 mg formulation compared to ibuprofen 250 mg
      alone, acetaminophen 650 mg alone, and to placebo. Subjects will be healthy males and females
      aged 18-40 years, inclusive, who are experiencing post-operative pain following surgical
      extraction of 3 or more third molar teeth. Following extraction, subjects must experience,
      within 5 hours, post-surgical pain of at least moderate severity (on a 4-point categorical
      scale), confirmed by a Visual Analog Pain Severity Rating Scale (VAS PSR) of at least 50 mm
      on a 100 mm VAS PSR scale. Eligible subjects will be randomized to receive a single oral dose
      of study medication under double-blind conditions and then evaluated on site for 12 hours
      following administration of study medication. Subjects will provide self-ratings of pain
      severity and pain relief at various time points using categorical and numerical scales.
      Additionally, subjects will also evaluate the time to first perceptible relief and time to
      meaningful relief using a double stopwatch method. Finally, at 12 hours, subjects will
      complete a categorical Global Evaluation of the study medication. A review of any reported
      adverse events will also be completed.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Outpatients who have undergone surgical extraction of 3 or more third molars, of which
             at least 2 must be a partial or complete bony mandibular impaction.

          -  Subject must have at least moderate pain on the 4-point categorical scale, confirmed
             by at least 50 mm on the 100 mm VAS PSR scale within approximately 5 hours (i.e., less
             than or equal to 5 hours, 15 minutes) after surgery is completed.

          -  Female subjects are not pregnant or breast feeding.

          -  Informed consent.

        Exclusion Criteria:

          -  Presence or history of any significant hepatic, renal, endocrine, cardiovascular,
             neurological, psychiatric, gastrointestinal, pulmonary, hematologic, or metabolic
             disorder determined by the Investigator to place the subject at increased risk,
             including the presence or history within 2 years of screening.

          -  Acute localized dental alveolar infection at the time of surgery that could confound
             the post-surgical evaluation.

          -  Hypersensitivity to ibuprofen, naproxen, aspirin, or any other NSAID; or to APAP,
             tramadol, other opioids, or to their combinations.