None listed
Conditions
Interventions
mometasone furoate nasal spray (once daily) Type of group
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.
Group name:Placebo Type of group
Placebo capsule three times daily for 10 days and placebo nasal spray twice daily for 15 days, followed by 14-day no-treatment observation.
Sponsors
SCHERING PLOUGH DEL PERU S.A.,
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:1. Facial pain, pressure or pain on palpation of the sinuses 2. Rinorrea 3. Postnasal drip 4. Sinus headache 5. Obstruction / nasal congestion Measure:Efficacy and safety of 200 mcg of intranasal MFNS 2 times / day compared with placebo, in the treatment of the signs and symptoms of acute rhinosinusitis acquired in the community. Timepoints:15 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:1. Facial pain, pressure or pain on palpation of the sinuses 2. Rinorrea 3. Postnasal drip 4. Sinus headache 5. Obstruction / nasal congestion Measure:Efficiency of 200 mcg of MFNS 2 times / day compared to amoxicillin for the main endpoint indicated in the previous section. Timepoints:15 days | — |
Countries
Canada, Mexico, Peru, Sweden, United States
Contacts
Public ContactJorge Timoteo
SCHERING PLOUGH DEL PERU S.A.
Outcome results
None listed