At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 778 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 Actual Use Trial In A Simulated OTC Environment of an Extended-Release Over-the-Counter NSAID
In Brief
A Phase 3 clinical trial evaluating Naproxen Sodium ER (BAYH6689) for Pain. Completed, enrolled 778 participants across 34 sites.
Detailed Summary
An actual use trial to demonstrate that consumers will not exceed the labeled daily dose of Aleve 24 Hour at an unacceptable rate. Two aspects of consumer use will be evaluated: 1) the frequency at which consumers exceed the label-defined daily dose, thus putting themselves at clinical risk, and 2) the reasons for exceeding the labeled daily dose.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPain
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
Enrollment StartSep 2011
First PostedSep 2011
Primary CompletionDec 2011
TodayJul 2026
First PostedSep 2, 2011
Enrollment StartSep 1, 2011
Primary CompletionDec 1, 2011
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 14.8 years ago
Interventions
Naproxen Sodium ER (BAYH6689)drug
BAYH6689; oral tablet used as needed upon incidence of pain