Phase 3
Completed N=472
The Confirmatory Study of TAU-284 in Pediatric Patients With Perennial Allergic Rhinitis
Perennial Allergic Rhinitis
Source: ClinicalTrials.gov NCT01861522 ↗
Enrolled (actual)
472
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] — -1.579; -1.110 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 safety 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] |
— | — |
| 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 for Symptoms of Allergic Rhinitis |
— | — |
| SECONDARY Adverse Events and Adverse Drug Reactions |
— | — |
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 rhinorrhea score and a mean sneezing score of at least 2 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 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 and have a chance to touch dogs or cats.
- 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 (NCT01861522). 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.