CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 290 enrolled
Drug / intervention
Ibuprofen 250 mg / Acetaminophen 500 mg +3 moredrug
Likely dose
Ibuprofen 250 mg / Acetaminophen 500 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/NCT02761980
NCT02761980Phase 3Completed
CompareCT.gov

A Phase 3, Double-blind, Randomized, Placebo-controlled, Full Factorial, Safety And Efficacy Study Comparing The Antipyretic Effects Of A Single Oral Dose Of Ibuprofen (Ibu) 250 Mg/ Acetaminophen (Apap) 500 Mg Caplets To Ibu 250 Mg And Apap 500 Mg Caplets In Healthy Male Volunteers With Fever Induced By An Endotoxin

Pfizer·interventional·Posted May 4, 2016·Updated Dec 7, 2018

In Brief

A Phase 3 clinical trial evaluating Ibuprofen 250 mg / Acetaminophen 500 mg, Ibuprofen 250 mg, and 2 other interventions for Fever. Completed, enrolled 290 participants across 1 site.

Detailed Summary

This is a single dose study that will evaluate the efficacy and safety of a Fixed Dose Combination Ibuprofen 250 mg/ Acetaminophen 500 mg tablet in healthy male patients with fever. Results for the Fixed Dose Combination product will be compared to the individual components Ibuprofen 250 mg and Acetaminophen 500 mg and also compared to placebo.

Study Details

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

Timeline

Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedMay 4, 2016
Enrollment StartDec 6, 2016
Primary CompletionDec 6, 2017
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 10.2 years ago

Interventions

Ibuprofen 250 mg / Acetaminophen 500 mgdrug

Ibuprofen 250 mg / Acetaminophen 500 mg

Ibuprofen 250 mgdrug

Ibuprofen 250 mg

Acetaminophen 500 mgdrug

1 APAP 500 mg caplet

Placebodrug

Placebo tablet