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:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2025-12-25 @ 2:37 AM
NCT ID:
NCT01135134
Eligibility Criteria:
Inclusion Criteria:
* Pediatric subjects with perennial allergic rhinitis who satisfy all of the following main criteria:
* Subjects having symptoms of perennial allergic rhinitis of moderate to severe degree, after the pretreatment observation period.
* Subjects confirmed to be allergic to non-seasonal environmental antigens (e.g., house dust-mite antigen).
* Male or female outpatients aged 5 to 15 years at the time of providing informed consent.
Exclusion Criteria:
* Subjects for whom any of the main exclusion criteria below is applicable will not be registered in this study.
* Subjects with coexisting tuberculous disease or lower respiratory tract infection and subjects who have a nasopharyngolaryngeal infection (acute upper respiratory tract infection, acute pharyngolaryngitis, or acute tonsillitis, etc.) requiring treatment at the time of registration
* Subjects with coexisting infections or systemic mycosis for which there are no effective antibiotics
* Subjects with repeated epistaxis
* Subjects who have nasal septum ulcers, nasal surgery, or nasal trauma, which have not healed
* Subjects with severe hepatic, renal, cardiac, hematological disease, diabetes mellitus, hypertension, or other serious coexisting diseases and whose general condition is poor
* Subjects with complication of vasomotor rhinitis or eosinophilic rhinitis.
* Subjects with nasal conditions (infectious sinusitis, hypertrophic rhinitis, acute or chronic rhinitis, nasal polyps, septal deviation, etc.) which may interfere with the evaluation of the efficacy of the study drug.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
5 Years
Maximum Age:
15 Years
Study:
NCT01135134
Study Brief:
Protocol Section:
NCT01135134