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

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ClinicalTrials.gov Identifier: NCT01900054
Recruitment Status : Completed
First Posted : July 16, 2013
Results First Posted : December 14, 2015
Last Update Posted : April 8, 2016
Sponsor:
Information provided by (Responsible Party):
Mitsubishi Tanabe Pharma Corporation

July 3, 2013
July 16, 2013
September 17, 2015
December 14, 2015
April 8, 2016
June 2013
November 2013   (Final data collection date for primary outcome measure)
Number of Patients With Adverse Events and Adverse Drug Reactions [ Time Frame: Up to Week 12 ]
Adverse events and adverse drug reactions [ Time Frame: Up to Week 12 ]
Complete list of historical versions of study NCT01900054 on ClinicalTrials.gov Archive Site
  • 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).
  • 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 ]
  • Change From Baseline in Individual Scores for Local Nasal Findings (Rhinoscopic Findings) [ Time Frame: Second enrollment, Week2, Week4, Week6, Week8, Week10 and Week 12 ]
  • Change From Baseline in Severity Score for Symptoms of Allergic Rhinitis [ Time Frame: baseline, Week2, Week4, Week6, Week8, Week10 and Week 12 ]
  • Influence of Activities in Daily Life(Study, Outing, Sleeping) [ Time Frame: Second enrollment, Week2, Week4, Week6, Week8, Week10 and Week 12 ]
  • Patient Impression of Nasal Symptoms(Sneezing, Rhinorrhea, Nasal Congestion, Nasal Pruritus, Eye Pruritus and Eye Tearing) [ Time Frame: Week 12 or suspension ]
  • Change from baseline in total score for the three major nasal symptoms [sneezing, rhinorrhea, and nasal congestion] [ Time Frame: baseline, Week2, Week4, Week6, Week8, Week10, Week 12 and final evaluation point ]
  • 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 ]
  • Change From Baseline in Individual Scores for Local Nasal Findings (Rhinoscopic Findings) [ Time Frame: Second enrollment, Week2, Week4, Week6, Week8, Week10 and Week 12 ]
  • Change From Baseline in Severity Score for Symptoms of Allergic Rhinitis [ Time Frame: baseline, Week2, Week4, Week6, Week8, Week10 and Week 12 ]
  • Influence of Activities in Daily Life(Study, Outing, Sleeping) [ Time Frame: Second enrollment, Week2, Week4, Week6, Week8, Week10 and Week 12 ]
  • Patient Impression of Nasal Symptoms(Sneezing, Rhinorrhea, Nasal Congestion, Nasal Pruritus, Eye Pruritus and Eye Tearing) [ Time Frame: Week 12 or suspension ]
Not Provided
Not Provided
 
A Long-Term Study of TAU-284 in Pediatric Patients With Perennial Allergic Rhinitis
Not Provided
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.
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.
Interventional
Phase 3
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Perennial Allergic Rhinitis
Drug: Bepotastine besilate
Two TAU-284 5mg tablets will be taken orally twice a day
Other Name: TALION 5mg tablets
Experimental: TAU-284
Two TAU-284 5mg tablets will be taken orally twice a day, once after breakfast and once after dinner (or before bed).
Intervention: Drug: Bepotastine besilate
Okubo K, Ichimura M, Koyama T, Susuta Y, Izaki H. Double-blind placebo-controlled study of bepotastine besilate in pediatric patients with perennial allergic rhinitis. Expert Opin Pharmacother. 2015;16(16):2395-408. doi: 10.1517/14656566.2015.1085511. Epub 2015 Sep 12.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
58
50
November 2013
November 2013   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
7 Years to 15 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT01900054
TAU-284-18
No
Not Provided
Not Provided
Mitsubishi Tanabe Pharma Corporation
Mitsubishi Tanabe Pharma Corporation
Not Provided
Study Director: KIMIHIRO OKUBO Nippon Medical School
Mitsubishi Tanabe Pharma Corporation
September 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP