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Evaluate Analgesic / Sedative Efficacy of Naproxen Sodium and Diphenhydramine in Patients With Postsurgical Dental Pain

NCT01495858 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 267

Last updated 2015-06-08

Study results available
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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.

Conditions

  • Pain, Postoperative

Interventions

DRUG

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

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.

DRUG

Naproxen Sodium 440 mg (BAYH6689)

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

DRUG

DPH 50 mg

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

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-12-31
Primary Completion
2012-02-29
Completion
2012-02-29

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01495858 on ClinicalTrials.gov