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The Confirmatory Study of TAU-284 in Pediatric Patients With Perennial Allergic Rhinitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01861522
Recruitment Status : Completed
First Posted : May 23, 2013
Results First Posted : December 15, 2015
Last Update Posted : December 15, 2015
Sponsor:
Information provided by (Responsible Party):
Mitsubishi Tanabe Pharma Corporation

Tracking Information
First Submitted Date  ICMJE May 19, 2013
First Posted Date  ICMJE May 23, 2013
Results First Submitted Date  ICMJE September 17, 2015
Results First Posted Date  ICMJE December 15, 2015
Last Update Posted Date December 15, 2015
Study Start Date  ICMJE April 2013
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 10, 2015)
Change From Baseline in Total Score for the Three Major Nasal Symptoms [Sneezing, Rhinorrhea, and Nasal Congestion] [ Time Frame: Baseline and Week 2 ]
Total score for the three major nasal symptoms (sneezing, rhinorrhea, and nasal congestion) were rated on 5-point scale ranging from 0 (no symptoms) to 4 (very severe).
Original Primary Outcome Measures  ICMJE
 (submitted: May 21, 2013)
Change from baseline in total score for the three major nasal symptoms [sneezing, rhinorrhea, and nasal congestion] (at final evaluation) [ Time Frame: Baseline and Week 2 ]
Change History Complete list of historical versions of study NCT01861522 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 21, 2013)
  • Change From Baseline in Total Score for the Three Major Nasal Symptoms [Sneezing, Rhinorrhea, and Nasal Congestion] [ Time Frame: baseline, Week1 and Week 2 ]
  • Change From Baseline in Individual Nasal Symptom Scores (Sneezing, Rhinorrhea, Nasal Congestion, and Impairment in Daily Activities) [ Time Frame: baseline, Week1 and Week 2 ]
  • Change From Baseline in Individual Scores for Local Nasal Findings (Rhinoscopic Findings) [ Time Frame: baseline, Week1 and Week 2 ]
  • Change From Baseline in Severity Score for Symptoms of Allergic Rhinitis [ Time Frame: Randomization, Week1 and Week 2 ]
  • Adverse Events and Adverse Drug Reactions [ Time Frame: Week 2 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Confirmatory Study of TAU-284 in Pediatric Patients With Perennial Allergic Rhinitis
Official Title  ICMJE A Confirmatory Study of TAU-284 in Pediatric Patients With Perennial Allergic Rhinitis (A Randomized, Double-blind, Placebo-controlled Study)
Brief 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.
Detailed Description This is a randomized, double-blind, placebo-controlled, 2-arm parallel-group comparative study to confirm the superiority of TAU-284 over placebo after two weeks of administration of TAU-284 (20 mg/day) or placebo to pediatric patients with perennial allergic rhinitis, with "the change from baseline in total nasal symptom score (total score for the three major nasal symptoms [sneezing, rhinorrhea, and nasal congestion])" as the primary endpoint; and to investigate safety of TAU-284.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Perennial Allergic Rhinitis
Intervention  ICMJE
  • Drug: Bepotastine besilate
    Two TAU-284 5mg tablets will be taken orally twice a day
    Other Name: TALION 5mg tablets
  • Drug: Placebo
    Two Placebo tablets will be taken orally twice a day
Study Arms  ICMJE
  • 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
  • Placebo Comparator: Placebo
    Two placebo tablets will be taken orally twice a day, once after breakfast and once after dinner (or before bed).
    Intervention: Drug: Placebo
Publications * 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.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 14, 2014)
473
Original Estimated Enrollment  ICMJE
 (submitted: May 21, 2013)
450
Actual Study Completion Date  ICMJE December 2013
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 7 Years to 15 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01861522
Other Study ID Numbers  ICMJE TAU-284-20
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mitsubishi Tanabe Pharma Corporation
Study Sponsor  ICMJE Mitsubishi Tanabe Pharma Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: KIMIHIRO OKUBO Nippon Medical School
PRS Account Mitsubishi Tanabe Pharma Corporation
Verification Date November 2015

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