drugset / Trial / NCT00751075

Effectiveness and Safety of Once or Twice Daily Mometasone Nasal Spray Versus Amoxicillin Versus Placebo for Treatment of Acute Rhinosinusitis (Phase 3 Study)(Study P02692)

NCT00751075

Phase 3 Completed 981 enrolled Organon and Co
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This study was conducted to compare the effectiveness and safety of mometasone nasal spray once daily or twice daily with amoxicillin or with placebo in treating the signs and symptoms of acute rhinosinusitis. Patients received mometasone nasal spray 2 sprays per nostril once daily, 2 sprays per nostril twice daily, amoxicillin 500 mg three times a day, or placebo three times a day. Patients on nasal spray were treated for 15 days and patients on amoxicillin or placebo were treated for 10 days. All patients were followed-up with a 14-day no-treatment observation period.

Timeline

Start
2003-12-01
Primary completion
2004-05-06
Completion
2004-06-22

Drugs

EvaluationDrugModalityDoseRoute
Comparator Amoxicillin Other / unclassified 500 mg
Comparator Mometasone furoate Other / unclassified 200 ug Intranasal

Indications