Maxigesic 325 Acute Dental Pain Study
Condition: Dental Pain
MeSH terms: Toothache
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine whether the analgesic effects of Maxigesic USA are
      greater than acetaminophen, ibuprofen or placebo.
    

Detailed description: 
      The combination of 500mg acetaminophen and 150mg ibuprofen has been shown to improve
      analgesia compared with the individual components, when given as 2 tablets (i.e. total of
      1,000/300 mg) 4 times a day.

      Recent concerns over the safety of acetaminophen have led to some regulatory agencies
      restricting the maximum dose of acetaminophen per tablet to 325 mg, while maintaining the
      maximum daily dose of 4000mg per day.

      A dosing regimen of three tablets of Maxigesic 325 four times a day gives a total daily dose
      of 3900mg acetaminophen and 1170mg ibuprofen.

      The primary objective of the study is to compare time-adjusted SPID of the VAS pain intensity
      scores up to 48 hours after the first dose of study medication among the four study groups.

      Secondary objectives are:

      To compare the time to onset of pain relief after the first dose of study drug defined as (i)
      perceptible and (ii) meaningful pain relief among the four study groups using the two
      stopwatch method.

      To compare the maximum VAS pain scores up to 48 hours after the first dose of study
      medication among the four study groups.

      To compare the response rates (response rate to be defined as the percentage of participants
      who reduce their pain intensity scores by at least 50% compared with the baseline VAS
      measure) among the four study groups.

      To compare the time to peak reduction in VAS pain intensity scores following the first dose
      of study medication among the four study groups.

      To compare the time to requirement for rescue medication among the four study groups.

      To compare the percentage of participants who use rescue medication among the four study
      groups.

      To compare the amount of rescue medication used (defined as number of tablets) among the four
      study groups.

      To compare the categorical global pain rating among the four study groups.

      Safety:

      To compare adverse event rates for the 48-hour study period and up to Day 30 among the four
      treatment groups.

      To compare the incidence of known specific NSAID and paracetamol side effects (e.g. GI
      ulceration or bleeding, indigestion/stomach pain, post-operative bleeding, bronchospasm, skin
      rashes, water retention, renal failure, thromboembolic events and evidence of clinical
      hepatitis) during the 48-hour study period and up to Day 30 among the four study groups.

      Planned hospital admissions and/or surgical operations for an illness or disease which
      existed before the study drug was given or the participant was randomized in the study will
      not be considered adverse events.
    

Intervention name(s): Maxigesic 325; Acetaminophen; Ibuprofen; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Maxigesic USA (acetaminophen 325 mg + ibuprofen 97.5mg), three tablets four times a day with food for 48 hours; Acetaminophen 325 mg, 3 tablets four times a day, with food for 48 hours; Ibuprofen 97.5mg, three tablets four times a day, with food for 48 hours.; placebo, three tablets four times a day, with food for 48 hours
Other intervention name(s): Maxigesic; paracetamol
Intervention MeSH terms: Acetaminophen; Ibuprofen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment