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

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

Outcome

Missed primary endpoint

Stopped (Business): “Based on business priorities. Not related to any safety or efficacy issue \& took place before data were unblinded or analyzed”

registry Mean Difference (Net) -0.44 (95% CI -1.14 to 0.25) NCT00423176 ↗

registry Mean Difference (Net) 8.8 (95% CI -0.5 to 18.2) NCT00423176 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Mometasone furoate	Other / unclassified	200 ug	Intranasal
Background	amoxicillin/clavulanic acid	Unknown	—	—

Indications