CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 267 enrolled
Drug / intervention
Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111) +2 moredrug
Likely dose
Naproxen Sodium 440 mg / DPH 25 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/NCT01495858
NCT01495858Phase 3Completed
CompareCT.gov

A Multicenter, Randomized, Double-Blind, Parallel Group Trial Assessing the Efficacy and Safety of Naproxen Sodium and Diphenhydramine Combination in Postsurgical Dental Pain With Phase Advanced Sleep

Bayer·interventional·Posted Dec 20, 2011·Updated Jun 8, 2015

In Brief

A Phase 3 clinical trial evaluating Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111), Naproxen Sodium 440 mg (BAYH6689), and 1 other intervention for Pain, Postoperative. Completed, enrolled 267 participants across 2 sites.

Detailed Summary

The objective of the study is to evaluate the efficacy and safety of a single oral dose of naproxen sodium 440 mg in combination with DPH (diphenhydramine) 25 mg in subjects with postsurgical dental pain and phase advanced sleep.

Study Details

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

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedDec 20, 2011
Enrollment StartDec 1, 2011
Primary CompletionFeb 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 14.5 years ago

Interventions

Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)drug

Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.

Naproxen Sodium 440 mg (BAYH6689)drug

Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.

DPH 50 mgdrug

Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.