CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 501 enrolled
Drug / intervention
Test naproxen sodium tablet +3 moredrug
Likely dose
Test naproxen sodium tablet 220 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/NCT03566979
NCT03566979Phase 3Completed
CompareCT.gov

A Randomized, Double-Blind, Placebo- and Active- Controlled, Efficacy and Safety Study of a Test Naproxen Sodium 220 mg Tablet in Postoperative Dental Pain

Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division·interventional·Posted Jun 25, 2018·Updated Apr 9, 2020

In Brief

A Phase 3 clinical trial evaluating Test naproxen sodium tablet, Commercial naproxen sodium tablet, and 2 other interventions for Post-operative Dental Pain. Completed, enrolled 501 participants across 1 site.

Detailed Summary

To evaluate analgesic onset, efficacy, and safety of a single dose of 440 mg of naproxen sodium administered as two Test Naproxen Sodium 220 mg tablets compared with two commercial naproxen sodium products (two naproxen sodium 220 mg tablets and two naproxen sodium 220 mg liquid gels capsules) and placebo in the dental pain model following third-molar extractions.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPost-operative Dental Pain
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
20192020202120222023202420252026
First PostedJun 25, 2018
Enrollment StartAug 13, 2018
Primary CompletionMar 26, 2019
Study CompletionApr 15, 2019
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 8.0 years ago

Interventions

Test naproxen sodium tabletdrug

Single dose of 2 test naproxen sodium 220 mg tablets

Commercial naproxen sodium tabletdrug

Single dose of 2 naproxen sodium 220 mg tablets

Commercial naproxen sodium liquid gels capsuledrug

Single dose of 2 naproxen sodium 220 mg liquid gel capsules

Placebo tabletdrug

2 placebo tablets