CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 253 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.

Search/NCT01383486
NCT01383486Phase 3Completed
CompareCT.gov

A Pilot Self Selection Trial of an Extended-Release Over-the-Counter Analgesic

Bayer·interventional·Posted Jun 28, 2011·Updated Oct 15, 2015

In Brief

A Phase 3 clinical trial evaluating Naproxen sodium ER (BAYH6689) and Advil for Pain. Completed, enrolled 253 participants across 10 sites.

Detailed Summary

A pilot trial to demonstrate that consumers can appropriately select Aleve 24 Hour for their own use based on expected duration of pain greater than 12 hours.

Study Details

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

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJun 28, 2011
Enrollment StartJul 1, 2011
Primary CompletionAug 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 15.0 years ago

Interventions

Naproxen sodium ER (BAYH6689)drug

Naproxen Sodium ER (BAYH6689): oral tablet upon incidence of pain

Advildrug

Commercially available Advil; oral caplet upon incidence of pain