Phase 3
Completed N=58
A Long-Term Study of TAU-284 in Pediatric Patients With Perennial Allergic Rhinitis
Perennial Allergic Rhinitis
Source: ClinicalTrials.gov NCT01900054 ↗
Enrolled (actual)
58
Serious AEs
0.0%
Results posted
Dec 2015
Primary outcomePrimary: Number of Patients With Adverse Events and Adverse Drug Reactions — 37; 2 participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients With Adverse Events and Adverse Drug Reactions |
37; 2 | — |
| SECONDARY Change From Baseline in Total Score for the Three Major Nasal Symptoms [Sneezing, Rhinorrhea, and Nasal Congestion] at Week2, Week4, Week6, Week8, Week10, Week 12 and Final Evaluation Point. |
-0.943; -1.388; -1.321; -1.433; -1.460; -1.451 | — |
| 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 for Symptoms of Allergic Rhinitis |
— | — |
| SECONDARY Influence of Activities in Daily Life(Study, Outing, Sleeping) |
— | — |
| SECONDARY Patient Impression of Nasal Symptoms(Sneezing, Rhinorrhea, Nasal Congestion, Nasal Pruritus, Eye Pruritus and Eye Tearing) |
— | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01900054). 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.