At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 312 enrolled
Drug / intervention
Naproxen Sodium ER (BAYH6689) +1 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.
A Multicenter, Double-Blind, Randomized, Parallel, Placebo-Controlled Trial Assessing the Analgesic Efficacy of a Single, Oral Dose of an Extended Release Naproxen Sodium Tablet in Postsurgical Dental Pain
In Brief
A Phase 3 clinical trial evaluating Naproxen Sodium ER (BAYH6689) and Placebo for Toothache. Completed, enrolled 312 participants across 3 sites.
Detailed Summary
To evaluate the analgesic efficacy of a single, oral dose of a naproxen sodium extended-release tablet, compared to placebo in postsurgical dental pain.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsToothache
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJun 2008
First PostedJul 2008
Primary CompletionAug 2008
TodayJul 2026
First PostedJul 22, 2008
Enrollment StartJun 1, 2008
Primary CompletionAug 1, 2008
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 17.9 years ago
Interventions
Naproxen Sodium ER (BAYH6689)drug
Analgesic efficacy in dental pain; per oral; 1 tablet extended release Naproxen Sodium; with a full glass of water within 4 hours post surgery
Placebodrug
Inactive ingredient; per oral; 1 lactose based tablet; with a full glass of water within 4 hours post surgery