CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 276 enrolled
Drug / intervention
Maxigesic IV +3 moredrug
Likely dose
Maxigesic IV 1000 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02689063
NCT02689063Phase 3Completed

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

AFT Pharmaceuticals, Ltd.·interventional·Posted Feb 23, 2016·Updated Jul 6, 2021

In Brief

A Phase 3 clinical trial evaluating Maxigesic IV, IV Acetaminophen, and 2 other interventions for Post Operative Pain. Completed, enrolled 276 participants across 2 sites.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedFeb 23, 2016
Enrollment StartOct 26, 2016
Primary CompletionJun 30, 2017
Study CompletionSep 15, 2017
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 10.4 years ago

Interventions

Maxigesic IVdrug

IV acetaminophen 1000 mg and IV ibuprofen 300 mg /100 mL solution for infusion, 100mL, every 6 hours for 48 hours

IV Acetaminophendrug

IV Acetaminophen 1000 mg/100 mL solution for infusion, 100mL, every 6 hours for 48 hours

IV Ibuprofendrug

IV Ibuprofen 300 mg/100 mL solution for infusion, 100mL, every 6 hours for 48 hours

Placebo IVdrug

Placebo IV- 100 mL intravenous saline for infusion, 100mL, every 6 hours for 48 hours