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NCT Number: NCT01900054

A Long-Term Study of TAU-284 in Pediatric Patients With Perennial Allergic Rhinitis

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.

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Key information

Conditions

Perennial Allergic Rhinitis Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Nose Diseases Otorhinolaryngologic Diseases Respiratory Hypersensitivity Respiratory Tract Diseases Rhinitis Rhinitis, Allergic Rhinitis, Allergic, Perennial

Age range

7 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Reserch site

Kanagawa, Japan

About this study

This is a multicenter,open-label, single-arm, uncontrolled study to evaluate the safety and efficacy of TAU-284 (20 mg/day) in pediatric patients with perennial allergic rhinitis for 12 weeks administration.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Bepotastine Besilate

Drug

Two TAU-284 5mg tablets will be taken orally twice a day

Other names: TALION 5mg tablets

Primary outcomes

  1. Number of Patients With Adverse Events and Adverse Drug Reactions

    Time frame: Up to Week 12

Secondary outcomes

  1. 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.

    Time frame: Baseline, Week2, Week4, Week6, Week8, Week10, Week 12 and Final Evaluation Point （up to Week 12）

    Total score for the three major nasal symptoms (sneezing, rhinorrhea, and nasal congestion) were rated on 5-point scale ranging from 0 (no symptom) to 4 (very severe).

  2. Change From Baseline in Individual Nasal Symptom Scores (Sneezing, Rhinorrhea, Nasal Congestion, and Impairment in Daily Activities)

    Time frame: baseline, Week2, Week4, Week6, Week8, Week10 and Week 12

  3. Change From Baseline in Individual Scores for Local Nasal Findings (Rhinoscopic Findings)

    Time frame: Second enrollment, Week2, Week4, Week6, Week8, Week10 and Week 12

  4. Change From Baseline in Severity Score for Symptoms of Allergic Rhinitis

    Time frame: baseline, Week2, Week4, Week6, Week8, Week10 and Week 12

  5. Influence of Activities in Daily Life(Study, Outing, Sleeping)

    Time frame: Second enrollment, Week2, Week4, Week6, Week8, Week10 and Week 12

  6. Patient Impression of Nasal Symptoms(Sneezing, Rhinorrhea, Nasal Congestion, Nasal Pruritus, Eye Pruritus and Eye Tearing)

    Time frame: Week 12 or suspension

Sponsors and collaborators

Lead sponsor

Tanabe Pharma Corporation

Industry

Registry information

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Jul 16, 2013
Registry last updated
Jan 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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