A Long-Term Study of TAU-284 in Pediatric Patients With Perennial Allergic Rhinitis (NCT01900054) | Clinical Trial Compass
CompletedPhase 3
A Long-Term Study of TAU-284 in Pediatric Patients With Perennial Allergic Rhinitis
Japan58 participantsStarted 2013-06
Plain-language summary
The objective of this study is to evaluate the long-term safety and efficacy of TAU-284 (Bepotastine besilate) in pediatric patients with perennial allergic rhinitis for 12 weeks administration.
Who can participate
Age range7 Years ā 15 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients aged between 7 and 15 years
* Patients who have received a diagnosis of perennial allergic rhinitis according to the diagnostic criteria
* Patients with a mean total score for the three major nasal symptoms \[sneezing, rhinorrhea, and nasal congestion\] of at least 3 on the basis of symptoms recorded in the nasal allergy diary during the observation period etc.
Exclusion Criteria:
* Patients with vasomotor rhinitis or eosinophilic rhinitis
* Patients who have concurrent nasal disease that may affect the efficacy of TAU-284
* Patients with a history of any of the nasal surgical procedures
* Patients with current or previous history of drug allergy
* Patients who concurrently have renal function abnormalities that may cause safety problems etc.
What they're measuring
1
Number of Patients With Adverse Events and Adverse Drug Reactions