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Maxigesic® IV Phase 3 Exposure Study

NCT04005755 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 232

Last updated 2021-09-01

Study results available
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Summary

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

Conditions

  • Postoperative Pain

Interventions

DRUG

Maxigesic® IV

acetaminophen 1000 mg + ibuprofen 300 mg, 100 ml solution for infusion

Sponsors & Collaborators

  • AFT Pharmaceuticals, Ltd.

    lead INDUSTRY

Principal Investigators

  • Ira Gottlieb, DPM · Chesapeake Research Group

  • Simon Carson, MD · Southern Clinical Trials Ltd

  • Gregory L Ruff, MD · Chapel Hill Research Group

  • Nigel Gilchrist, MD · CGM Research Trust

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-22
Primary Completion
2020-06-30
Completion
2020-07-07
FDA Drug
Yes

Countries

  • United States
  • New Zealand

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 NCT04005755 on ClinicalTrials.gov