drugset / Trial / NCT00423176

The Study of Nasonex® Compared With Placebo for the Relief of Symptoms Associated With Acute Bacterial Sinusitis When Used With Antibiotics (Study P04824AM3)

NCT00423176

Phase 3 Terminated 237 enrolled Organon and Co
RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this study is to evaluate the efficacy and safety of Nasonex® (mometasone furoate nasal spray), when used together with an antibiotic, for the relief of symptoms associated with acute bacterial sinusitis. Efficacy will be based on both subjective (assessment of symptom severity by the patient) and objective measurements (computed tomography \[CT\] imaging of the sinuses).

Timeline

Start
2006-12
Primary completion
2008-06
Completion
2008-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Mometasone furoate Other / unclassified 200 ug Intranasal
Background amoxicillin/clavulanic acid Unknown

Indications