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)

PHASE3CompletedINTERVENTIONAL
Enrollment

981

Participants

Timeline

Start Date

December 1, 2003

Primary Completion Date

May 6, 2004

Study Completion Date

June 22, 2004

Conditions
Acute Rhinosinusitis
Interventions
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

All Listed Sponsors
lead

Organon and Co

INDUSTRY

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) | Biotech Hunter | Biotech Hunter