CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 304 enrolled
Drug / intervention
Acetaminophen/naproxen sodium Dose A +5 moredrug
Likely dose
Not stated in 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/NCT04447040
NCT04447040Phase 2Completed
CompareCT.gov

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Five Strengths of a Fixed Combination of Acetaminophen/Naproxen Sodium in Postoperative Dental Pain

Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division·interventional·Posted Jun 25, 2020·Updated Mar 24, 2025

In Brief

A Phase 2 clinical trial evaluating Acetaminophen/naproxen sodium Dose A, Acetaminophen/naproxen sodium Dose B, and 4 other interventions for Pain. Completed, enrolled 304 participants across 1 site.

Detailed Summary

Study assessing the relative efficacy of five strengths of a fixed combination of acetaminophen and naproxen sodium is being investigated to help inform selection of dose(s) for further development and to evaluate the safety of a fixed combination of naproxen sodium and acetaminophen.

Study Details

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

Timeline

Phase 2CompletedFinished
202120222023202420252026
First PostedJun 25, 2020
Enrollment StartNov 9, 2020
Primary CompletionApr 9, 2021
Study CompletionMay 3, 2021
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 6.0 years ago

Interventions

Acetaminophen/naproxen sodium Dose Adrug

Acetaminophen/naproxen sodium Dose A administered as a single two-tablet dose.

Acetaminophen/naproxen sodium Dose Bdrug

Acetaminophen/naproxen sodium Dose B administered as a single two-tablet dose.

Acetaminophen/naproxen sodium Dose Cdrug

Acetaminophen/naproxen sodium Dose C administered as a single two-tablet dose.

Acetaminophen/naproxen sodium Dose Ddrug

Acetaminophen/naproxen sodium Dose D administered as a single two-tablet dose.

Acetaminophen/naproxen sodium Dose Edrug

Acetaminophen/naproxen sodium Dose E administered as a single two-tablet dose.

Placebodrug

Placebo tablets administered as a single two-tablet dose.