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Ibuprofen/Acetaminophen FDC for Fever
NCT02761980Phase 3
Key facts
- Status
- Completed
- Start
- Dec 2016
- Primary completion
- Dec 2017
- Countries
- 1
- Sponsor
- Pfizer
- Modality
- Small Molecules
- Conditions
- fever
01
Overview
Phase 3, randomised, double-blind trial of ibuprofen and acetaminophen in fever (4 arms), sponsored by Pfizer. Primary endpoint: Time Weighted Sum of Temperature Difference From 0 to 8 Hours. Started Dec 2016; status: completed.
02
Design
4 arms- Study design
- RandomizedDouble-blind
Ibuprofen 250 mg / Acetaminophen 500 mg
Single dose of 2 caplets of Ibuprofen 125 mg / Acetaminophen 250 mg
Ibuprofen 250 mg
Single dose of 2 caplets of IBU 125 mg
Acetaminophen 500 mg
Single dose of 1 APAP 500 mg caplet + 1 placebo caplet
Placebo
Single dose of 2 caplets of Placebo
03
Endpoints
Primary
Time Weighted Sum of Temperature Difference From 0 to 8 Hours
Secondary
Time Weighted Sum of Temperature Differences From Baseline Through Hours 2
Time Weighted Sum of Temperature Differences From Baseline Through Hours 4
Time Weighted Sum of Temperature Differences From Baseline Through Hours 6
Time to Return to Normal Body Temperature
Time to Rescue Medication
Time Weighted Sum of Temperature Difference From 6 to 8 Hours
04
Results
Primary endpoints met
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