Efficacy and Safety of Desloratadine vs. Fexofenadine 180 mg. vs. Placebo for Treating Seasonal A… (NCT00783146) | Clinical Trial Compass
CompletedPhase 4
Efficacy and Safety of Desloratadine vs. Fexofenadine 180 mg. vs. Placebo for Treating Seasonal Allergic Rhinitis (SAR) (Study P04054)
728 participantsStarted 2004-08-01
Plain-language summary
This was a randomized, double-blind, parallel-group, multicenter study that used both an active control (fexofenadine) and a placebo control to evaluate desloratadine 5 mg once daily during a 15-day treatment period. The active treatments and placebo were allocated in a 2:2:1 ratio.
Who can participate
Age range12 Years
SexALL
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Inclusion Criteria:
* have demonstrated their willingness to participate in the study and comply with its procedures, including adherence to dosing and visit schedules by signing a written informed consent (the parent/guardian of a subject under 18 years of age also had to sign the informed consent form);
* have been 12 years of age or older, of either sex and any race;
* have had at least a 2-year history (self-reported history was acceptable) of seasonal allergic rhinitis occurring during the same season(s) as the current study;
* have been skin test positive (skin prick test with a wheal diameter at least 3 mm larger than the diluent control or intradermal testing with a wheal diameter at least 7 mm larger than the diluent control) at Screening, or within 12 months prior to the Screening Visit, to an appropriate seasonal allergen, which could include seasonal molds, prevalent in the geographical area of the study site during the study period;
* if female and of childbearing potential (including women who were less than 1 year postmenopausal and women who became sexually active during the study), have been using an acceptable method of birth control (eg, hormonal contraceptive, medically prescribed IUD, condom in combination with spermicide) or be surgically sterilized (eg, hysterectomy or tubal ligation);
* if female and of childbearing potential, have had a negative urine pregnancy test at Baseline;
* have been free of any clinically significant disease (other than SAR) …
What they're measuring
1
Compare the efficacy of the study treatments with respect to the change from Baseline in the mean AM self-rated instantaneous total symptom score (TSS) (not including nasal congestion) averaged over the 15 days of treatment