Comparison of the Effects of Desloratadine and Placebo in the Relief of Nasal Symptom Scores in S… (NCT00867191) | Clinical Trial Compass
CompletedPhase 4
Comparison of the Effects of Desloratadine and Placebo in the Relief of Nasal Symptom Scores in Subjects With Seasonal Allergic Rhinitis to Cypress Pollen (Study P02836)
233 participantsStarted 2002-02-01
Plain-language summary
The purpose of this study was to demonstrate the efficacy (% of change from baseline) of desloratadine to improve the nasal total symptom score of SAR to cypress pollen.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Patients must demonstrate their willingness to participate in the study and comply with its procedures by signing a written informed consent.
* Patients must be \>=18 years of age, of either gender.
* 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 (e.g. hormonal contraceptive, medically prescribed intrauterine device, condom in combination with spermicide) or be surgically sterilized (e.g. hysterectomy or tubal ligation). Women of childbearing potential who are not currently sexually active must agree and consent to use one of the above-mentioned methods, should they become sexually active while participating in the study.
* Patients must be in good general health; i.e., they must be free of any clinically significant disease (other than SAR to cypress pollen) that could interfere with study evaluations.
* Patients must understand and be able to adhere to the measurement, dosing and visit schedules, and agree to report concomitant medications and adverse events to the investigator or designee.
* Patients must have at least a two-year history (self-reported being acceptable) of intermittent allergic rhinitis specifically from January to March
* Patients must be clinically symptomatic with SAR to cypress pollen at Visit 2 (Day 0): the total (nasal + non-nasal) symptom score must be \>=8 with a nasal congestion …
What they're measuring
1
The primary objective was to demonstrate the efficacy (as percentage of change from baseline) of desloratadine to improve the nasal total symptom score of SAR to cypress pollen.