CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 326 enrolled
Drug / intervention
Naproxen sodium 440 mg/DPH 50 mg (BAY98-7111) +1 moredrug
Likely dose
Naproxen sodium 440 mg/DPH 50 mg (BAY98-7111)from 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/NCT01365052
NCT01365052Phase 3Completed
CompareCT.gov

A Multicenter, Randomized, Double-Blind, Placebo Controlled, Parallel Group Safety and Tolerability Trial of Naproxen Sodium/ Diphenhydramine Combination in an OTC Population

Bayer·interventional·Posted Jun 3, 2011·Updated Jun 8, 2015

In Brief

A Phase 3 clinical trial evaluating Naproxen sodium 440 mg/DPH 50 mg (BAY98-7111) and Placebo for Pain. Completed, enrolled 326 participants across 19 sites.

Detailed Summary

The purpose of this trial is to see how safe the combination of naproxen sodium 440 mg and diphenhydramine hydrochloride (DPH) 50 mg (the investigational product) is compared to placebo (capsules containing no drug) when taken for 10 days.

Study Details

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

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJun 3, 2011
Enrollment StartMay 1, 2011
Primary CompletionJul 1, 2011
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 15.1 years ago

Interventions

Naproxen sodium 440 mg/DPH 50 mg (BAY98-7111)drug

2 capsules each containing naproxen sodium 220 mg /diphenhydramine hydrochloride (DPH) 25 mg are taken orally with a full glass of water approximately 30 minutes prior to bedtime for 10 consecutive days

Placebodrug

2 placebo capsules are taken orally with a full glass of water 30 minutes prior to bedtime for 10 consecutive days