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 PHASE3 COMPLETED

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.

Details

Lead sponsor	Organon and Co
Phase	PHASE3
Status	COMPLETED
Enrolment	981
Start date	Mon Dec 01 2003 00:00:00 GMT+0000 (Coordinated Universal Time)
Completion	Tue Jun 22 2004 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

• Acute Rhinosinusitis

Interventions

• mometasone furoate nasal spray (MFNS)
• MFNS
• Amoxicillin
• Placebo