CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 300 enrolled
Drug / intervention
Naproxen Sodium ER (BAYH6689) +3 moredrug
Likely dose
Naproxen Sodium ER (BAYH6689) 660 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/NCT01389284
NCT01389284Phase 3Completed
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A Randomized, Double-Blind, Placebo Controlled Trial to Assess the Analgesic Efficacy and Safety of Extended Release Naproxen Sodium Tablets in Postsurgical Dental Pain

Bayer·interventional·Posted Jul 8, 2011·Updated Aug 25, 2015

In Brief

A Phase 3 clinical trial evaluating Naproxen Sodium ER (BAYH6689), Naproxen Sodium IR (Aleve, BAYH6689), and 2 other interventions for Pain, Postoperative. Completed, enrolled 300 participants across 1 site.

Detailed Summary

The objective is to evaluate pain relief of the extended release naproxen sodium 660 mg tablet compared to commercial naproxen sodium 220 mg tablet over 24 hours in patients with postsurgical dental pain.

Study Details

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

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJul 8, 2011
Enrollment StartJun 1, 2011
Primary CompletionSep 1, 2011
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 15.0 years ago

Interventions

Naproxen Sodium ER (BAYH6689)drug

660 mg Naproxen Sodium extended release tablet, orally administered once daily for 24 hours

Naproxen Sodium IR (Aleve, BAYH6689)drug

220 mg Naproxen Sodium instant release tablet, orally administered 3 times daily (TID) for 24 hours

Naproxen Sodium ER Placebodrug

Matching placebo of 660 mg Naproxen Sodium ER for 24 hours

Naproxen Sodium IR Placebodrug

Matching placebo of 220 mg Naproxen Sodium IR (Aleve) for 24 hours