CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 712 enrolled
Drug / intervention
Naproxen sodium 440 mg / DPH 50 mg (BAY98-7111) +3 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/NCT01280591
NCT01280591Phase 3Completed
CompareCT.gov

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

Bayer·interventional·Posted Jan 21, 2011·Updated Jun 8, 2015

In Brief

A Phase 3 clinical trial evaluating Naproxen sodium 440 mg / DPH 50 mg (BAY98-7111), Naproxen sodium 220 mg / DPH 50 mg (BAY98-7111), and 2 other interventions for Pain, Postoperative. Completed, enrolled 712 participants across 2 sites.

Detailed Summary

The objective of the study is to evaluate the efficacy and safety of a single oral dose of two dose combinations of naproxen sodium and diphenhydramine (DPH) to demonstrate that naproxen sodium/DPH combination provides added clinical benefit to sleep improvement than either single ingredient alone in subjects with post-surgical dental pain and phase advanced sleep.

Study Details

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

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJan 21, 2011
Enrollment StartOct 1, 2010
Primary CompletionJan 1, 2011
Study CompletionFeb 1, 2011
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 15.4 years ago

Interventions

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

Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose

Naproxen sodium 220 mg / DPH 50 mg (BAY98-7111)drug

Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose

Naproxen sodium 440 mg (BAYH6689)drug

Participants received two Naproxen sodium 220 mg tablets orally, single dose

DPH 50 mgdrug

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