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BAY12-8039: 5 Days for Sinusitis vs Placebo

NCT00492024 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 374

Last updated 2013-11-26

Study results available
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Summary

The purpose of the study is to evaluate the effectiveness and safety of Avelox in a 5 day treatment of adult patients with acute bacterial sinusitis and to measure the amount of time it takes for symptom relief. Avelox is currently not approved for the 5 day treatment of acute bacterial sinusitis, therefore in this study Avelox is considered an investigational drug. In this study Avelox will be compared to placebo.

Conditions

  • Sinusitis

Interventions

DRUG

Moxifloxacin (Avelox, BAY12-8039)

Moxifloxacin - 400 mg once a day for 5 days

DRUG

Placebo

Placebo - 380 mg Microcrystalline Cellulose

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-01-31
Primary Completion
2008-03-31
Completion
2008-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
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 NCT00492024 on ClinicalTrials.gov