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Evaluate Analgesic/Sedative Efficacy of Naproxen Sodium and Diphenhydramine

NCT01118273 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 162

Last updated 2015-06-08

Study results available
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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

Conditions

  • Sleep

Interventions

DRUG

Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg

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

DRUG

Naproxen Sodium 440 mg (BAYH6689)

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

DRUG

Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg

One dose of naproxen sodium 220 mg plus diphenhydramine 50 mg

DRUG

Naproxen Sodium 220 mg (BAYH6689)

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

DRUG

DPH 50mg

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

DRUG

Ibuprofen 400 mg / Diphenhydramine citrate 76 mg

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

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2008-01-31
Primary Completion
2008-02-29
Completion
2008-02-29

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 NCT01118273 on ClinicalTrials.gov