Maxigesic 325 Acute Dental Pain Study
Condition: Dental Pain
MeSH terms: Toothache
Intervention: Maxigesic 325; Acetaminophen; Ibuprofen; Placebo
Intervention description: 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
Intervention MeSH terms: Acetaminophen; Ibuprofen
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 408.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No

Summary:

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

Eligibility criteria:

        Inclusion Criteria:

          -  Provides written informed consent before initiation of any study-related procedures.

          -  Males and females aged at least 10 years and not more than 60 years old on the day of
             consent.

          -  Undergoing dental surgery for the extraction of at least 2 impacted third molar teeth.

          -  A resting VAS pain intensity score at baseline (within 6 hours after the completion of
             surgery) of greater than or equal to 40 mm on a 100 mm VAS scale with 0 = no pain and
             100 = worst pain imaginable.

        Exclusion Criteria:

          -  Has taken any NSAID or acetaminophen within 12 hours prior to the stat of surgery
             other than asprin less than or equal to 150 mg/day

          -  Subjects who have received any anaesthetics within 24 hours prior to surgery

          -  Hypersensitivity to opioids

          -  Known to be pregnant or possibly pregnant

          -  Women of childbearing potential who are unwilling to take adequate contraceptive
             precautions, i.e., hormonal contraceptive, an intrauterine device, double-barrier
             method, or abstinence. A women of childbearing potential is defined as any female who
             is less than 2 years post-menopausal or has not undergone a partial or total
             hysterectomy or surgical sterilization, e.g. bilateral tubal ligation, bilateral
             oophorectomy.

          -  Women of childbearing potential who are unwilling to undergo an urine pregnancy test.

          -  Suffering from a neurological disorder relating to pain perception or any acute or
             chronic condition that, in the opinion of the investigator, makes the subject
             unsuitable from an efficacy or safety perspective.

          -  In the opinion of the investigator, unable to understand the visual analogue pain
             score or comply with the protocol requirements.

          -  Currently, or in the last 30 days, has been in a clinical trial involving another
             study drug.

          -  Currently treated with an ACE inhibitor, warfarin, steroid (other than nasal steroids
             or topical steroids with the approval of the investigator) cyclosporin, tacrolimus or
             methotrexate, or any other medication felt by the investigator to interfere with
             safety or efficacy evaluations.

          -  Participant weight < 50 kg or > 120 kg.

          -  Has a history of drug or alcohol abuse.

          -  Suffering from any other disease or condition which, in the opinion of the
             investigator, means that it would not be in the participants best interests to
             participant in the study.