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)

Efficacy and Safety of 200 mcg QD or 200 mcg BID Mometasone Furoate Nasal Spray (MFNS) vs Amoxicillin vs Placebo as Primary Treatment of Subjects With Acute Rhinosinusitis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 981 (actual)
• Sponsor: Organon and Co · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Rhinosinusitis

Interventions

Type	Name	Description
DRUG	mometasone furoate nasal spray (MFNS)	Placebo capsules three times daily for 10 days, and MFNS 50 mcg/spray, 2 sprays in each nostril once daily in the morning and placebo nasal spray once daily in the evening for 15 days, followed by 14-day no-treatment observation period
DRUG	MFNS	Placebo capsules three times daily for 10 days, and MFNS 50 mcg/spray, 2 sprays in each nostril twice daily for 15 days followed by 14-day no-treatment observation period
DRUG	Amoxicillin	Amoxicillin 500 mg/capsule, one capsule 3 times a day for 10 days and placebo nasal spray twice daily for 15 days, followed by a 14-day no-treatment observation period
DRUG	Placebo	Placebo capsule three times daily for 10 days and placebo nasal spray twice daily for 15 days, followed by 14-day no-treatment observation

Timeline

• Start date: 2003-12-01
• Primary completion: 2004-05-06
• Completion: 2004-06-22
• First posted: 2008-09-11
• Last updated: 2024-08-15