CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 664 enrolled
Drug / intervention
Test acetaminophen +3 moredrug
Likely dose
Test 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/NCT03224403
NCT03224403Phase 3Completed
CompareCT.gov

A Randomized, Double-Blind, Placebo- and Active- Controlled, Single-Dose, Efficacy and Safety Study of a Test Acetaminophen 500 mg Tablet in Postoperative Dental Pain

Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division·interventional·Posted Jul 21, 2017·Updated Apr 15, 2021

In Brief

A Phase 3 clinical trial evaluating Test acetaminophen, Commercial acetaminophen, and 2 other interventions for Post-operative Dental Pain. Completed, enrolled 664 participants across 1 site.

Detailed Summary

To evaluate analgesic onset, efficacy, and safety of 1000 mg acetaminophen administered as two Test Acetaminophen 500 mg tablets (Test ACM) compared with 1000 mg acetaminophen administered as two commercial acetaminophen 500 mg caplets (ACM) and 400 mg ibuprofen administered as two commercial ibuprofen 200 mg liquid-filled capsules (IBU) in the dental pain model following third-molar extractions.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPost-operative Dental Pain
CountriesUnited States
CollaboratorsJohnson & Johnson Consumer and Personal Products Worldwide

Timeline

Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedJul 21, 2017
Enrollment StartJul 19, 2017
Primary CompletionApr 4, 2018
Study CompletionApr 12, 2018
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 8.9 years ago

Interventions

Test acetaminophendrug

single dose of 2 Test acetaminophen 500 mg tablets

Commercial acetaminophendrug

single dose of 2 acetaminophen 500 mg caplets

Commercial ibuprofendrug

Single dose of 2 ibuprofen 200 mg Liquid-filled Capsules

Placebodrug

2 placebo caplets