At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 497 enrolled
Drug / intervention
Naproxen Sodium ER (BAYH6689)drug
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.
An Open Label, Actual Use Study in Consumers Taking an Extended-Release Over the Counter NSAID in a Naturalistic Setting
In Brief
A Phase 3 clinical trial evaluating Naproxen Sodium ER (BAYH6689) for Pain. Completed, enrolled 497 participants across 24 sites.
Detailed Summary
The purpose of this Study is to assess how subjects will use the investigational product in an uncontrolled, naturalistic environment.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPain
CountriesUnited States
CollaboratorsPegus Research, Inc.
Timeline
Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJul 2008
First PostedSep 2008
Primary CompletionNov 2008
TodayJul 2026
First PostedSep 12, 2008
Enrollment StartJul 1, 2008
Primary CompletionNov 1, 2008
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 17.8 years ago
Interventions
Naproxen Sodium ER (BAYH6689)drug
Consumer use of Extended Release Naproxen Sodium