Study for the Treatment of Intermittent Allergic Rhinitis With Desloratadine (Study P04683) (NCT00406783) | Clinical Trial Compass
CompletedPhase 3
Study for the Treatment of Intermittent Allergic Rhinitis With Desloratadine (Study P04683)
547 participantsStarted 2006-08
Plain-language summary
This study will investigate the effectiveness of desloratadine in treating subjects with allergic rhinitis (AR) who meet the criteria for intermittent allergic rhinitis.
Who can participate
Age range12 Years
SexALL
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Inclusion Criteria:
The subject must meet ALL of the criteria listed below for entry:
* For this study, the diagnosis of IAR is not based solely on the current episode of AR. Subjects must have at least a 2 year history of AR consistent with IAR (defined as symptoms of allergic rhinitis present less than four days per week or for less than four consecutive weeks per year); the current episode can count as the second year.
* Subjects must be 12 years of age and older, of either sex and of any race.
* At the Run-In Visit, subjects must be sufficiently symptomatic, with a T5SS 12-hour AM-PRIOR (reflective) symptoms severity score of at least 6.
* In order for a subject to qualify at the Baseline Visit, the sum of the daily averages of the diary recordings of the 12-hour AM PRIOR + PM-PRIOR (reflective) T5SS collected during Days -4 to -1 and the AM PRIOR T5SS on the morning of the Baseline Visit (Day 1) must be \>= 30.
* Subjects must have a positive skin-prick test at screening to one or more allergens in the GA2LEN (or the usually used local) panel of seasonal and perennial allergens. Subjects must demonstrate an antigen-induced skin prick wheal at least 3 mm in diameter greater than diluent control. The positive tests must include the allergen(s) prevalent while this study is active.
* Subjects must be free of any clinically significant disease, other than IAR, which would interfere with the study evaluations.
* Subjects, or parents/legal guardians, must give written informā¦
What they're measuring
1
The Change From Baseline in the 12-hour AM/PM-PRIOR (Reflective) Total 5 Symptom Score (T5SS) From Subject Daily Diaries Averaged Over Treatment Days 1 to 15