NCT02689063

Maxigesic IV Phase 3 Bunionectomy Study

Maxigesic IV Bunionectomy Study- A Phase 3, Randomized, Double-Blind, Multiple-Dose, Parallel-Group and Placebo-Controlled Study

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 276 (actual)
• Sponsor: AFT Pharmaceuticals, Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Conditions

• Post Operative Pain

Interventions

Type	Name	Description
DRUG	Maxigesic IV	IV acetaminophen 1000 mg and IV ibuprofen 300 mg /100 mL solution for infusion, 100mL, every 6 hours for 48 hours
DRUG	IV Acetaminophen	IV Acetaminophen 1000 mg/100 mL solution for infusion, 100mL, every 6 hours for 48 hours
DRUG	IV Ibuprofen	IV Ibuprofen 300 mg/100 mL solution for infusion, 100mL, every 6 hours for 48 hours
DRUG	Placebo IV	Placebo IV- 100 mL intravenous saline for infusion, 100mL, every 6 hours for 48 hours

Timeline

• Start date: 2016-10-26
• Primary completion: 2017-06-30
• Completion: 2017-09-15
• First posted: 2016-02-23
• Last updated: 2021-07-06
• Results posted: 2021-07-06

Locations

2 sites across 1 country: United States