Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:51 PM
Ignite Modification Date:
2025-12-24 @ 4:51 PM
NCT ID:
NCT00750750
Eligibility Criteria:
Inclusion Criteria:
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 Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Study:
NCT00750750
Study Brief:
Protocol Section:
NCT00750750