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Trial record 1 of 1 for:    TAU-284-17
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A Confirmatory Study of TAU-284 in Pediatric Patients With Perennial Allergic Rhinitis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01425632
First Posted: August 30, 2011
Last Update Posted: December 14, 2015
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.
Information provided by (Responsible Party):
Mitsubishi Tanabe Pharma Corporation
  Purpose
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 the dose response, safety, and plasma concentrations of TAU-284.

Condition Intervention Phase
Perennial Allergic Rhinitis Drug: TAU-284 Drug: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Confirmatory Study of TAU-284 in Pediatric Patients With Perennial Allergic Rhinitis (A Randomized, Double-blind, Placebo-controlled Study)

Resource links provided by NLM:


Further study details as provided by Mitsubishi Tanabe Pharma Corporation:

Primary Outcome Measures:
  • 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 ]
    Total score for the three major nasal symptoms (sneezing, rhinorrhea, and nasal congestion) were rated on 4-point scale ranging from 0 (no symptoms) to 3 (severe) .


Secondary Outcome Measures:
  • Change From Baseline in Total Score for the Three Major Nasal Symptoms [Sneezing, Rhinorrhea, and Nasal Congestion] [ Time Frame: Week 2 ]
  • Change From Baseline in Individual Nasal Symptom Scores (Sneezing, Rhinorrhea, Nasal Congestion, and Impairment in Daily Activities) [ Time Frame: Week 2 ]
  • Change From Baseline in Individual Scores for Local Nasal Findings (Rhinoscopic Findings) [ Time Frame: Week 2 ]
  • Change From Baseline in Severity Score [ Time Frame: Week 2 ]
  • Adverse Events and Adverse Drug Reactions [ Time Frame: Week 2 ]
  • Plasma Concentrations of Unchanged TAU-284 (Bepotastine Besilate) (at a Total of 3 Time Points, i.e., Before and 2 (±1) Hours After Study-drug Administration at Week 1 and Before Study-drug Administration at Week 2) [ Time Frame: Week 2 ]

Enrollment: 490
Study Start Date: August 2011
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TAU-284 Low Drug: TAU-284
TAU-284 Low
Experimental: TAU-284 High Drug: TAU-284
TAU-284 High
Placebo Comparator: Placebo Drug: Placebo
Placebo

Detailed Description:
This is a randomized, double-blind, placebo-controlled, 3-arm parallel-group comparative study to confirm the superiority of TAU-284 over placebo after two weeks of administration of TAU-284 (10 mg/day or 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 the dose response, safety, and plasma concentrations of TAU-284.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients aged between 7 and 15 years
  • Patients with a weight of at least 20 kg
  • Patients who have received a diagnosis of perennial allergic rhinitis according to the diagnostic criteria
  • Patients with a mean rhinorrhea score of at least 2 and a mean total score for the three major nasal symptoms [sneezing, rhinorrhea, and nasal congestion] of at least 4 on the basis of symptoms recorded in the nasal allergy diary during the observation period

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
  • Patients with current or previous history of drug allergy
  • Patients who concurrently have renal function abnormalities that may cause safety problems
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01425632


Locations
Japan
Reserch site
Chubu, Japan
Reserch site
Hokuriku, Japan
Reserch site
Kanto, Japan
Reserch site
Kinki, Japan
Reserch site
Kyusyu, Japan
Sponsors and Collaborators
Mitsubishi Tanabe Pharma Corporation
Investigators
Study Director: Kimihiro Okubo, M.D. Ph.D. Department of Otorhinolaryngology, Nippon Medical School
  More Information

Responsible Party: Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier: NCT01425632     History of Changes
Other Study ID Numbers: TAU-284-17
First Submitted: August 28, 2011
First Posted: August 30, 2011
Results First Submitted: September 17, 2015
Results First Posted: December 14, 2015
Last Update Posted: December 14, 2015
Last Verified: September 2015

Keywords provided by Mitsubishi Tanabe Pharma Corporation:
TAU-284
Bepotastine besilate
Histamine H1 receptor antagonists

Additional relevant MeSH terms:
Rhinitis
Rhinitis, Allergic
Rhinitis, Allergic, Perennial
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases