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)

• Status: Completed
• Trial end date: 2004-06-22
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Amoxicillin; Mometasone Furoate

Criteria

Inclusion Criteria:

Subjects must:

• have been diagnosed with acute rhinosinusitis

• have had signs and symptoms of rhinosinusitis for at least 7 but not more than 28 days prior to Baseline

• have had a major symptom score >=5 and <=12 at the Screening and Baseline, and no more than 3 of the 5 major individual symptoms were to be rated as "severe"

• be >=12 years old

• be in good health overall and normal laboratory tests

• not be pregnant, intending to become pregnant or intending to impregnate.

Exclusion Criteria:

Subjects who:

• have a history of chronic rhinosinusitis or who had undergone sinus or nasal surgery for chronic rhinosinusitis in the 6 months prior to Screening

• have fever >=101°F and/or persistent severe unilateral facial pain/tooth pain; and/or orbital or peri-orbital facial swelling; and/or dental involvement; and/or worsening symptoms after initial improvement

• have a history of symptomatic seasonal allergic rhinitis who were exposed to allergenic pollens

• have asthma with FEV1<65% of predicted volume in the past 3 months or who have had an exacerbation within the past 30 days

• have nasal polyps, Kartagener's syndrome, and otitis or atrophic rhinitis

• have certain comorbid conditions or contraindications to certain drug therapies