NCT04005755

Maxigesic® IV Phase 3 Exposure Study

A Phase 3, Open-Label, Multiple-Dose, Single-Arm Exposure Study of Maxigesic® IV in Patients With Acute Pain Following Orthopedic, General or Plastic Surgery

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 232 (actual)
• Sponsor: AFT Pharmaceuticals, Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

Combined administration of acetaminophen and ibuprofen has been shown to provide superior analgesia over administration of comparable doses of either component alone or placebo, when given as an intravenous formulation or as a solid oral tablet in the postoperative setting. The superior efficacy of the combination does not appear to come at the expense of tolerability. A previous study of Maxigesic® IV in bunionectomy patients found that there were no differences between patients treated with repeated doses of Maxigesic® IV and those treated with intravenous acetaminophen, ibuprofen or placebo in the rate of discontinuations due to adverse events (AEs), the overall incidence of treatment-emergent AEs (TEAEs) or the severity of TEAEs. The incidence of common TEAEs (affecting ≥ 10% of the study population), including gastrointestinal disorders, nervous system disorders, general disorders and administration site conditions, and skin and subcutaneous tissue disorders, was not changed due to combined administration of acetaminophen and ibuprofen in Maxigesic® IV. This study aims to determine the tolerability of repeated doses of Maxigesic® IV over an extended period of exposure (≥ 48 hours).

Conditions

• Postoperative Pain

Interventions

Type	Name	Description
DRUG	Maxigesic® IV	acetaminophen 1000 mg + ibuprofen 300 mg, 100 ml solution for infusion

Timeline

• Start date: 2019-07-22
• Primary completion: 2020-06-30
• Completion: 2020-07-07
• First posted: 2019-07-02
• Last updated: 2021-09-01
• Results posted: 2021-09-01

Locations

4 sites across 2 countries: United States, New Zealand

Regulatory

• FDA-regulated drug study