Effectiveness and Safety of Once or Twice Daily Mometasone Nasal Spray Versus Amoxicillin Versus Placebo for Treatment of Acute Rhinosinusitis (Study P02683)

SCHERING PLOUGH DEL PERU S.A.,0 个研究点目标入组 0 人开始时间: 2003年3月11日最近更新: 2023年9月4日

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•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.

•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

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