CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 123 enrolled
Drug / intervention
FDC IBU/APAP 250 mg/500 mg +1 moredrug
Likely dose
FDC IBU/APAP 250 mg/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/NCT02837952
NCT02837952Phase 3Completed
CompareCT.gov

A Phase 3, Double-blind, Randomized Safety And Efficacy Study Comparing Multiple Administrations Of Ibu 250 Mg/Apap 500 Mg (Administered As Two Tablets Of Ibu/Apap 125 Mg/250 Mg) To Placebo In The Treatment Of Post Surgical Dental Pain In Adult Subjects

Pfizer·interventional·Posted Jul 20, 2016·Updated Mar 5, 2018

In Brief

A Phase 3 clinical trial evaluating FDC IBU/APAP 250 mg/500 mg and Placebo for Pain. Completed, enrolled 123 participants across 1 site.

Detailed Summary

This study is being conducted to determine the overall analgesic efficacy and safety of a fixed-dose ibuprofen 250 mg / acetaminophen 500 mg formulation compared to placebo in subjects who are experiencing post operative pain following surgical extraction of 3 or more third molar teeth. A review of any reported adverse events will also be completed.

Study Details

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

Timeline

Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedJul 20, 2016
Enrollment StartAug 31, 2016
Primary CompletionFeb 1, 2017
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 10.0 years ago

Interventions

FDC IBU/APAP 250 mg/500 mgdrug

FDC IBU/APAP 250 mg/500 mg

Placebodrug

Placebo