None listed
Conditions
Interventions
200 mg nasal spray mometasone furoate once a day Type of group
200 mg of MFNS 1 time / day in the morning (placebo aereosol per overnight) for 15 days with 1 placebo capsule of amoxicillin 3 times / day for 10 days.
Group name:Placebo Type of group
Placebo spray 2 times / day (in the morning and at night) for 15 days with 1 placebo capsule of amoxicillin 3 times / day for 10 days.
Sponsors
SCHERING PLOUGH RESEARCH INSTITUTE,
Eligibility
Inclusion criteria
Inclusion criteria: 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 years old be in good health overall and normal laboratory tests not be pregnant, intending to become pregnant or intending to impregnate.
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Sum of rhinorrhea, posterior nasal drip, congestion / nasal congestion, sinus headache and pain / pressure / facial sensitivity to palpation over the paranasal sinuses. Measure:Average score of main AM / PM symptoms during the 15-day treatment phase. Timepoints:day 15 | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:The first day of active treatment was statistically significantly different from placebo, and remained thereafter. Measure:The time until the start of the action in the score of the main symptoms. Timepoints:Throughout the treatment period | — |
Countries
Canada, Mexico, Peru, Sweden
Outcome results
None listed