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
Study type: Interventional
Phase: Phase 3

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.
    

Detailed description: 
      This is a 12-hour, 4-arm, 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 (administered
      as two caplets of 125 mg/250 mg IBU/APAP) 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, otherwise healthy, 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. Upon completion of the baseline scales, 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. At
      0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 hours post dose time points,
      subjects will provide: self-ratings of pain severity using the numerical and categorical
      PSRs; and self-ratings of pain relief at each time point using a categorical pain relief
      rating scale. At 12 hours, subjects will also complete a 6-point categorical Global
      Evaluation of the study medication. Additionally, subjects will also evaluate the time to
      first perceptible relief and time to meaningful relief using a double stopwatch method up to
      12 hours post-dose or until the time of first rescue medication use, whichever is sooner. A
      review of any reported adverse events will also be completed.
    

Intervention name(s): Ibuprofen 250 mg / Acetaminophen 500 mg; Ibuprofen 250 mg; Acetaminophen 650 mg; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 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
Other intervention name(s): IBU 250 / APAP 500; IBU 250; APAP 650
Intervention MeSH terms: Acetaminophen; Ibuprofen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: ibuprofen; acetaminophen; pain; molar extraction