Maxigesic IV Phase 3 Bunionectomy Study
Condition: Post Operative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to determine the clinical efficacy and safety of Maxigesic IV,
      acetaminophen IV, Ibuprofen IV versus placebo IV for the treatment of acute postoperative
      pain after bunionectomy
    

Detailed description: 
      AFT Pharmaceuticals Ltd. has been developing a fixed-dose combination of acetaminophen 1000mg
      and ibuprofen 300mg/100mL solution for infusion (Maxigesic IV) for the temporary relief of
      postoperative pain, when administration by intravenous route is clinically justified by an
      urgent need to treat pain or hyperthermia and/or when other routes of administration not
      possible.

      A phase 3 efficacy study (AFT-MXIV-07) is proposed to determine the analgesic effects of the
      fixed dose combination product Maxigesic IV versus its individual components (acetaminophen
      IV and ibuprofen IV) and placebo in participants with acute post-operative pain after
      bunionectomy.

      The primary efficacy objective is to determine the efficacy of Maxigesic IV, acetaminophen
      IV, Ibuprofen IV versus placebo IV as measured by the summed pain intensity difference (SPID)
      (calculated as a time-weighted average) over 0-48 hours (SPID-48) after time 0.

      Other secondary efficacy endpoints are:

      VAS Pain intensity difference (PID) at each scheduled assessment time point after Time 0 VAS
      Pain intensity score at each scheduled assessment time point VAS SPID over 0 to 6 hours
      (SPID-6), over 0 to 12 hours (SPID-12), and over 0 to 24 hours (SPID-24) after Time 0

      Summed pain relief (TOTPAR) (calculated as a time-weighted average) over 0 to 6 hours
      (TOTPAR-6), over 0 to 12 hours (TOTPAR-12), over 0 to 24 hours (TOTPAR-24) after Time 0, and
      over 0 to 48 hours (TOTPAR-48) after Time 0

      Time to onset of analgesia (measured as time to perceptible pain relief confirmed by
      meaningful pain relief) using the two-stopwatch method Pain relief score on a 5-point
      categorical scale at each scheduled time point after Time 0

      Peak pain relief

      Time to peak pain relief

      Time to first perceptible pain relief

      Time to meaningful pain relief

      Proportion of subjects using rescue medication

      Time to first use of rescue medication (duration of analgesia)

      Total use of rescue analgesia over 0 to 24 hours and over 0 to 48 hours Patient's global
      evaluation of study drug
    

Intervention name(s): Maxigesic IV; IV Acetaminophen; IV Ibuprofen; Placebo IV
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): IV acetaminophen 1000 mg and IV ibuprofen 300 mg /100 mL solution for infusion, 100mL, every 6 hours for 48 hours; IV Acetaminophen 1000 mg/100 mL solution for infusion, 100mL, every 6 hours for 48 hours; IV Ibuprofen 300 mg/100 mL solution for infusion, 100mL, every 6 hours for 48 hours; Placebo IV- 100 mL intravenous saline for infusion, 100mL, every 6 hours for 48 hours
Other intervention name(s): Maxigesic; Acetaminophen; Ibuprofen; Placebo
Intervention MeSH terms: Acetaminophen; Ibuprofen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Analgesic