CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 374 enrolled
Drug / intervention
Moxifloxacin (Avelox, BAY12-8039) +1 moredrug
Likely dose
Moxifloxacin (Avelox, BAY12-8039) 400 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00492024
NCT00492024Phase 3Completed
CompareCT.gov

Prospective, Multicenter, Randomized, Double-Blind, Placebo Controlled Trial to Evaluate the Efficacy and Safety of Moxifloxacin 400 mg QD for 5 Days Versus Placebo in the Treatment of Acute Bacterial Sinusitis

Bayer·interventional·Posted Jun 27, 2007·Updated Nov 26, 2013

In Brief

A Phase 3 clinical trial evaluating Moxifloxacin (Avelox, BAY12-8039) and Placebo for Sinusitis. Completed, enrolled 374 participants across 51 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSinusitis
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 27, 2007
Enrollment StartJan 1, 2005
Primary CompletionMar 1, 2008
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 19.0 years ago

Interventions

Moxifloxacin (Avelox, BAY12-8039)drug

Moxifloxacin - 400 mg once a day for 5 days

Placebodrug

Placebo - 380 mg Microcrystalline Cellulose