Study of Nasal Symptom Relief and Side Effects in Hayfever Patients Treated With Aerius (Deslorat… (NCT00805584) | Clinical Trial Compass
CompletedPhase 4
Study of Nasal Symptom Relief and Side Effects in Hayfever Patients Treated With Aerius (Desloratadine)(P03442)
311 participantsStarted 2003-05
Plain-language summary
The purpose of this study was to test the effectiveness and side effects of desloratadine (Aerius) in patients with hayfever. Patients took desloratadine once a day for 15 days. At the end of therapy, they scored how severe their hayfever symptoms were and how they responded to therapy. Side effects were recorded.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Subjects must demonstrate their willingness to participate in the study and comply with its procedures by signing a written informed consent.
* Subjects must be \>=18 years of age, of either sex and any race.
* Women of childbearing potential (includes women who are less than 1 year postmenopausal and women who become sexually active) must be using or agree to use an acceptable method of birth control. Women who are not currently sexually active must agree and consent to use some sort of contraception should they become sexually active while participating in the study.
* Subjects must be in general good health, i.e., they must be free of any clinically significant disease (other than SAR) that would interfere with study evaluations.
* Subjects must understand and be able to adhere to the dosing and visit schedules, and agree to report concomitant medications and adverse events to the Investigator or designee.
* Subjects must have at least a positive history, self-reported history of signs and symptoms is acceptable, of recurring seasonal allergic rhinitis
* Subjects must be clinically symptomatic with SAR at Visit 2 (Baseline): the total (nasal + non-nasal) symptom score must be \>=8 points with a nasal congestion score of \>=2, and the non-nasal symptom score must be \>=2. Subjects may be rescheduled up two additional times for the qualifying visit if they do not meet the minimum symptom scores.
* Women of childbearing potential must have be negative p…