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:
2025-12-26 @ 10:45 PM
Ignite Modification Date:
2025-12-26 @ 10:45 PM
NCT ID:
NCT00152412
Eligibility Criteria:
Inclusion Criteria:
* At Visit 1:
* Male or female outpatients aged 2 to 6 years old.
* Subjects suffering from allergic rhinitis (perennial and/or seasonal) and symptomatic as attested by the Daily Record Card (DRC).
* At Visit 2:
* Respected wash-out periods for the forbidden medication.
Exclusion Criteria:
* • Presence of asthma requiring treatment by inhaled corticosteroids.
* Atopic dermatitis or urticaria requiring antihistamine treatment or the administration of oral or topical corticosteroids, or any other disease requiring the administration of oral or topical corticosteroids, immunomodulatory drugs, anti-inflammatory, or cytotoxic drugs.
* Use during the course of the study, or during the specific wash-out periods, of any of the following medications: intranasal or systemic corticosteroids (within 7 days), ketotifen (within 7 days), nedocromil or cromoglicate (within 7 days), loratadine and desloratadine (within 7 days), other antihistamines (within 3 days) or decongestants (per os, nasal spray, or drops - within 3 days), or any other concomitant medications that, in the opinion of the Investigator, interfered with the study.
* Initiation or change of dose of an immunotherapy regimen during the course of the study.
Sex:
ALL
Minimum Age:
2 Years
Maximum Age:
6 Years
Study:
NCT00152412
Study Brief:
Protocol Section:
NCT00152412