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

NCT01280591 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 712

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 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.

Conditions

  • Pain, Postoperative

Interventions

DRUG

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

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

DRUG

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

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

DRUG

Naproxen sodium 440 mg (BAYH6689)

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

DRUG

DPH 50 mg

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

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-10-31
Primary Completion
2011-01-31
Completion
2011-02-28

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 NCT01280591 on ClinicalTrials.gov