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

Phase 1

• Conditions: -J019 Acute sinusitis, unspecified; Acute sinusitis, unspecified; J019

• Registration Number: PER-008-03
• Lead Sponsor: SCHERING PLOUGH DEL PERU S.A.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2003-03-11
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 0

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 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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified