Maxigesic® IV Phase 3 Exposure Study
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Intervention: Maxigesic® IV
Intervention description: acetaminophen 1000 mg + ibuprofen 300 mg, 100 ml solution for infusion
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 232.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Analgesic

Summary:

      The study aims to determine the tolerability of repeated doses of Maxigesic® IV over an
      extended period of exposure.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Is male or female ≥ 18 years of age.

          -  Is classified by the anesthesiologist as P1 to P2 in the American Society of
             Anesthesiologists (ASA) Physical Status Classification System.

          -  Requires multiple doses of parenterally administered nonopioid analgesics over
             multiple days as a result of surgery (non-laparoscopic general, plastic or orthopedic
             surgery).

          -  Has an expected stay in facility ≥ 48 hours.

          -  Has a body weight ≥ 45 kg.

          -  If female and of childbearing potential, is nonlactating and nonpregnant.

          -  If female, is either not of childbearing potential (defined as postmenopausal for at
             least 1 year or surgically sterile [bilateral tubal ligation, bilateral oophorectomy,
             or hysterectomy]) or practicing 1 of the following medically acceptable methods of
             birth control: i) Hormonal methods such as oral, implantable, injectable, or
             transdermal contraceptives for a minimum of 1 full cycle (based on the subject's usual
             menstrual cycle period) before study drug administration; ii) Total abstinence from
             sexual intercourse since the last menses before study drug administration through
             completion of final study visit; iii) Intrauterine device (IUD); iv) Double-barrier
             method (condoms, sponge, diaphragm, or vaginal ring with spermicidal jellies or
             cream).

          -  Is able to provide written informed consent to participate in the study and able to
             understand the procedures and study requirements.

          -  Must voluntarily sign and date an informed consent form (ICF) that is approved by an
             Institutional Review Board (IRB) before the conduct of any study procedure.

          -  Is willing and able to remain at the study site for at least 48 hours and to attend a
             follow-up visit at 7 ± 2 days after the last dose of study drug.

        Exclusion Criteria:

          -  Has a known history of allergic reaction or clinically significant intolerance to
             acetaminophen, aspirin, opioids, or any nonsteroidal anti-inflammatory drugs (NSAIDs,
             including ibuprofen); history of NSAID-induced bronchospasm (subjects with the triad
             of asthma, nasal polyps, and chronic rhinitis are at greater risk for bronchospasm and
             should be considered carefully); or hypersensitivity, allergy, or significant reaction
             to sulfa (including sulfonamide) medicines, ingredients of the study drug, or any
             other drugs used in the study including anesthetics and antibiotics that may be
             required on the day of surgery.

          -  Has experienced any surgical complications or other issues that, in the opinion of the
             Investigator, could compromise the safety of the subject if he or she participates in
             the study or could confound the results of the study.

          -  Has a known or suspected history of alcoholism or drug abuse or misuse within 2 years
             of screening or evidence of tolerance or physical dependence before dosing with study
             drug.

          -  Has any clinically significant unstable cardiac, respiratory, neurological,
             immunological, hematological, or renal disease or any other condition that, in the
             opinion of the Investigator, could compromise the subject's welfare, ability to
             communicate with the study staff, or otherwise contraindicate study participation.

          -  Has a history or current diagnosis of a significant psychiatric disorder that, in the
             opinion of the Investigator, would affect the subject's ability to comply with the
             study requirements.

          -  Has tested positive either on the urine drug screen or on the alcohol breathalyzer
             test. Subjects who test positive and can produce a prescription for the medication
             from their physician may be considered for study enrolment at the discretion of the
             Investigator.

          -  Has a history of a clinically significant (Investigator opinion) gastrointestinal (GI)
             event within 6 months before screening or has any history of peptic or gastric ulcers
             or GI bleeding.

          -  Has a surgical or medical condition of the GI or renal system that might significantly
             alter the absorption, distribution, or excretion of any drug substance.

          -  Is considered by the Investigator, for any reason to be an unsuitable candidate to
             receive the study drug.

          -  Is receiving systemic chemotherapy, has an active malignancy of any type, or has been
             diagnosed with cancer within 5 years before Screening (excluding treated squamous or
             basal cell carcinoma of the skin).

          -  Is currently receiving anticoagulants (e.g. heparin or warfarin).

          -  Has received a course of systemic corticosteroids (either oral or parenteral) within 3
             months before screening (inhaled nasal steroids and regional/limited area application
             of topical corticosteroids (Investigator discretion) are allowed).

          -  Has a history of chronic use (defined as daily use for > 2 weeks) of NSAIDs, opiates,
             or glucocorticoids (except inhaled nasal steroids and regional/limited topical
             corticosteroids), for any condition within 6 months before study drug administration.
             Aspirin at a daily dose of ≤ 325 mg is allowed for cardiovascular prophylaxis if the
             subject has been on a stable dose regimen for ≥ 30 days before screening and has not
             experienced any relevant medical problem.

          -  Has a significant renal or hepatic disease, as indicated by clinical laboratory
             assessment (results ≥ 3 times the upper limit of normal [ULN] for any liver function
             test, including aspartate aminotransferase [AST], alanine aminotransferase [ALT], or
             creatinine ≥ 1.5 times the ULN).

          -  Has any clinically significant laboratory finding at screening that, in the opinion of
             the Investigator, contraindicates study participation.

          -  Previously participated in another clinical study of Maxigesic® IV or received any
             investigational drug or device or investigational therapy within 30 days before
             Screening.