Phase 3
Completed N=490
A Confirmatory Study of TAU-284 in Pediatric Patients With Perennial Allergic Rhinitis
Perennial Allergic Rhinitis
Source: ClinicalTrials.gov NCT01425632 ↗
Enrolled (actual)
490
Serious AEs
0.0%
Results posted
Dec 2015
Primary outcomePrimary: Change From Baseline in Total Score for the Three Major Nasal Symptoms [Sneezing, Rhinorrhea, and Nasal Congestion] (at Final Evaluation) — -0.84; -0.92; -0.70 units on a scale
Summary
The objectives of this study are: to confirm the superiority of TAU-284 over placebo after two weeks of administration to pediatric patients with perennial allergic rhinitis, and to investigate the dose response, safety, and plasma concentrations of TAU-284.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Total Score for the Three Major Nasal Symptoms [Sneezing, Rhinorrhea, and Nasal Congestion] (at Final Evaluation) |
-0.84; -0.92; -0.70 | — |
| SECONDARY Change From Baseline in Total Score for the Three Major Nasal Symptoms [Sneezing, Rhinorrhea, and Nasal Congestion] |
— | — |
| SECONDARY Change From Baseline in Individual Nasal Symptom Scores (Sneezing, Rhinorrhea, Nasal Congestion, and Impairment in Daily Activities) |
— | — |
| SECONDARY Change From Baseline in Individual Scores for Local Nasal Findings (Rhinoscopic Findings) |
— | — |
| SECONDARY Change From Baseline in Severity Score |
— | — |
| SECONDARY Adverse Events and Adverse Drug Reactions |
— | — |
| SECONDARY Plasma Concentrations of Unchanged TAU-284 (Bepotastine Besilate) (at a Total of 3 Time Points, i.e., Before and 2 (±1) Hours After Study-drug Administration at Week 1 and Before Study-drug Administration at Week 2) |
— | — |
Eligibility Criteria
Inclusion Criteria
- Patients aged between 7 and 15 years
- Patients with a weight of at least 20 kg
- Patients who have received a diagnosis of perennial allergic rhinitis according to the diagnostic criteria
- Patients with a mean rhinorrhea score of at least 2 and a mean total score for the three major nasal symptoms [sneezing, rhinorrhea, and nasal congestion] of at least 4 on the basis of symptoms recorded in the nasal allergy diary during the observation period
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 who have a positive result for pollen antigens which are dispersed during the study period
- Patients who have a positive result for dog dander or cat dander antigen
- Patients with current or previous history of drug allergy
- Patients who concurrently have renal function abnormalities that may cause safety problems
Data sourced from ClinicalTrials.gov (NCT01425632). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.