CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 162 enrolled
Drug / intervention
Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg +5 moredrug
Likely dose
Naproxen Sodium 440 mg (BAYH6689) / DPH 50mgfrom 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/NCT01118273
NCT01118273Phase 4Completed
CompareCT.gov

A Double-Blind, Randomized, Pilot Study Assessing the Analgesic and Hypnotic Effect of Naproxen Sodium and Diphenhydramine Combination in Dental Pain

Bayer·interventional·Posted May 6, 2010·Updated Jun 8, 2015

In Brief

A Phase 4 clinical trial evaluating Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg, Naproxen Sodium 440 mg (BAYH6689), and 4 other interventions for Sleep. Completed, enrolled 162 participants across 1 site.

Detailed Summary

The objectives of the study are to evaluate the analgesic and hypnotic efficacy of naproxen sodium and diphenhydramine combination when compared to naproxen sodium, diphenhydramine, and an ibuprofen and diphenhydramine combination

Study Details

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

Timeline

Phase 4CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 6, 2010
Enrollment StartJan 1, 2008
Primary CompletionFeb 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 16.2 years ago

Interventions

Naproxen Sodium 440 mg (BAYH6689) / DPH 50mgdrug

Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.

Naproxen Sodium 440 mg (BAYH6689)drug

Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.

Naproxen Sodium 220 mg (BAYH6689) / DPH 50mgdrug

One dose of naproxen sodium 220 mg plus diphenhydramine 50 mg

Naproxen Sodium 220 mg (BAYH6689)drug

Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.

DPH 50mgdrug

Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.

Ibuprofen 400 mg / Diphenhydramine citrate 76 mgdrug

Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.