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Maxigesic IV Phase 3 Bunionectomy Study

NCT02689063 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 276

Last updated 2021-07-06

Study results available
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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

Conditions

  • Post Operative Pain

Interventions

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

Sponsors & Collaborators

  • AFT Pharmaceuticals, Ltd.

    lead INDUSTRY

Principal Investigators

  • Stephen E Daniels, DO · Optimal Research LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-10-26
Primary Completion
2017-06-30
Completion
2017-09-15

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02689063 on ClinicalTrials.gov