MedTrace Logo

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

NCT00423176 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 237

Last updated 2024-05-20

Study results available
· View outcomes & findings →

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).

Conditions

  • Sinusitis

Interventions

DRUG

MFNS and antibiotic

MFNS BID for 29 days plus amoxicillin/clavulanic acid BID for 10 days

DRUG

Matching Placebo nasal spray plus antibiotic

Matching placebo nasal spray BID for 29 days plus amoxicillin/clavulanic acid BID for 10 days

Sponsors & Collaborators

  • Organon and Co

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-12-31
Primary Completion
2008-06-30
Completion
2008-06-30

More Related Trials

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 NCT00423176 on ClinicalTrials.gov