Status:
COMPLETED
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)
Lead Sponsor:
Organon and Co
Conditions:
Acute Rhinosinusitis
Eligibility:
All Genders
12+ years
Phase:
PHASE3
Brief 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 rhinos...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 22 2004
Estimated Enrollment :
981 Patients enrolled
Trial Details
Trial ID
NCT00751075
Start Date
December 1 2003
End Date
June 22 2004
Last Update
August 15 2024
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