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Actual Use Trial of Naproxen Sodium

NCT01427803 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 778

Last updated 2015-10-15

Study results available
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Summary

An actual use trial to demonstrate that consumers will not exceed the labeled daily dose of Aleve 24 Hour at an unacceptable rate. Two aspects of consumer use will be evaluated: 1) the frequency at which consumers exceed the label-defined daily dose, thus putting themselves at clinical risk, and 2) the reasons for exceeding the labeled daily dose.

Conditions

Interventions

DRUG

Naproxen Sodium ER (BAYH6689)

BAYH6689; oral tablet used as needed upon incidence of pain

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2011-12-31
Completion
2011-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
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 NCT01427803 on ClinicalTrials.gov