CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 290 enrolled
Drug / intervention
440 mg naproxen sodium with 1000 mg acetaminophen +4 moredrug
Likely dose
440 mg naproxen sodium with 1000 mg acetaminophenfrom 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/NCT03879408
NCT03879408Phase 2Completed
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Randomized, Double-Blind, Placebo And Active Controlled, Study To Evaluate Two Strengths Of Concomitantly Dosed Naproxen Sodium With Acetaminophen, Compared With Naproxen Sodium and Hydrocodone/Acetaminophen In Postoperative Dental Pain

Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division·interventional·Posted Mar 18, 2019·Updated Dec 5, 2022

In Brief

A Phase 2 clinical trial evaluating 440 mg naproxen sodium with 1000 mg acetaminophen, 220 mg naproxen sodium with 650 mg acetaminophen, and 3 other interventions for Pain. Completed, enrolled 290 participants across 1 site.

Detailed Summary

Study assessing efficacy and safety of concomitantly dosed naproxen sodium with acetaminophen, compared with naproxen sodium, hydrocodone/acetaminophen and Placebo in a postoperative dental pain.

Study Details

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

Timeline

Phase 2CompletedFinished
2020202120222023202420252026
First PostedMar 18, 2019
Enrollment StartMay 28, 2019
Primary CompletionNov 7, 2019
Study CompletionNov 13, 2019
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 7.3 years ago

Interventions

440 mg naproxen sodium with 1000 mg acetaminophendrug

440 mg naproxen sodium with 1000 mg acetaminophen administered as a single dose of two naproxen sodium 220 mg tablets and two acetaminophen 500 mg tablets

220 mg naproxen sodium with 650 mg acetaminophendrug

220 mg naproxen sodium with 650 mg acetaminophen administered as a single dose of one naproxen sodium 220 mg tablet and two acetaminophen 325 mg tablets and one placebo tablet

10 mg hydrocodone + 650 mg acetaminophendrug

10 mg hydrocodone with 650 mg acetaminophen administered as a single dose of two hydrocodone 5 mg + acetaminophen 325 mg tablets and two placebo tablets

440 mg naproxen sodiumdrug

440 mg naproxen sodium administered as a single dose of two naproxen sodium 220 mg tablets and two placebo tablets

Placebo tabletdrug

Single dose of four placebo tablets