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

Sponsor
Mitsubishi Tanabe Pharma Corporation (Industry)
Overall Status
Completed
CT.gov ID
NCT01861522
Collaborator
(none)
473
Enrollment
2
Locations
2
Arms
8
Duration (Months)
236.5
Patients Per Site
29.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Bepotastine besilate
  • Drug: Placebo
 Phase 3

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 Design

Study Type:
Interventional
Actual Enrollment :
473 participants
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)
Study Start Date :
Apr 1, 2013
Actual Primary Completion Date :
Dec 1, 2013
Actual Study Completion Date :
Dec 1, 2013

Arms and Interventions

Arm Intervention/Treatment
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).

Drug: Bepotastine besilate
Two TAU-284 5mg tablets will be taken orally twice a day
Other Names:
  • TALION 5mg tablets

    		•
    Placebo Comparator: Placebo

    Two placebo tablets will be taken orally twice a day, once after breakfast and once after dinner (or before bed).

    Drug: Placebo
    Two Placebo tablets will be taken orally twice a day

    Outcome Measures

    Primary Outcome Measures

    1. Change From Baseline in Total Score for the Three Major Nasal Symptoms [Sneezing, Rhinorrhea, and Nasal Congestion] [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).

    Secondary Outcome Measures

    1. Change From Baseline in Total Score for the Three Major Nasal Symptoms [Sneezing, Rhinorrhea, and Nasal Congestion] [baseline, Week1 and Week 2]

    2. Change From Baseline in Individual Nasal Symptom Scores (Sneezing, Rhinorrhea, Nasal Congestion, and Impairment in Daily Activities) [baseline, Week1 and Week 2]

    3. Change From Baseline in Individual Scores for Local Nasal Findings (Rhinoscopic Findings) [baseline, Week1 and Week 2]

    4. Change From Baseline in Severity Score for Symptoms of Allergic Rhinitis [Randomization, Week1 and Week 2]

    5. Adverse Events and Adverse Drug Reactions [Week 2]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    7 Years to 15 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Reserch site Fukuoka Japan
    2 Reserch site Toyama Japan

    Sponsors and Collaborators

    • Mitsubishi Tanabe Pharma Corporation

    Investigators

    • Study Director: KIMIHIRO OKUBO, Nippon Medical School

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mitsubishi Tanabe Pharma Corporation
    ClinicalTrials.gov Identifier:
    NCT01861522
    Other Study ID Numbers:
    • TAU-284-20
    First Posted:
    May 23, 2013
    Last Update Posted:
    Dec 15, 2015
    Last Verified:
    Nov 1, 2015
    Keywords provided by Mitsubishi Tanabe Pharma Corporation
    TAU-284
    Bepotastine besilate
    Histamine H1 receptor antagonists
    children
    Additional relevant MeSH terms:
    Rhinitis
    Rhinitis, Allergic
    Rhinitis, Allergic, Perennial
    Bepotastine besilate

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title TAU-284 Placebo
    Arm/Group Description TAU-284 10mg twice daily for 2 weeks TAU-284 placebo twice daily for 2 weeks
    Period Title: Overall Study
    STARTED 240 232
    COMPLETED 237 232
    NOT COMPLETED 3 0

    Baseline Characteristics

    Arm/Group Title TAU-284 Placebo Total
    Arm/Group Description TAU-284 10mg twice daily for 2 weeks TAU-284 placebo twice daily for 2 weeks Total of all reporting groups
    Overall Participants 240 232 472
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    10.3
    (2.4)
    10.4
    (2.4)
    10.4
    (2.4)
    Sex: Female, Male (Count of Participants)
    Female
    108
    45%
    92
    39.7%
    200
    42.4%
    Male
    132
    55%
    140
    60.3%
    272
    57.6%

    Outcome Measures

    1. Primary Outcome
    Title Change From Baseline in Total Score for the Three Major Nasal Symptoms [Sneezing, Rhinorrhea, and Nasal Congestion]
    Description 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).
    Time Frame Baseline and Week 2

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title TAU-284 Placebo
    Arm/Group Description TAU-284 10mg twice daily for 2 weeks TAU-284 placebo twice daily for 2 weeks
    Measure Participants 240 232
    Least Squares Mean (Standard Error) [units on a scale]
    -1.579
    (0.090)
    -1.110
    (0.092)
    2. Secondary Outcome
    Title Change From Baseline in Total Score for the Three Major Nasal Symptoms [Sneezing, Rhinorrhea, and Nasal Congestion]
    Description
    Time Frame baseline, Week1 and Week 2

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title
    Arm/Group Description
    3. Secondary Outcome
    Title Change From Baseline in Individual Nasal Symptom Scores (Sneezing, Rhinorrhea, Nasal Congestion, and Impairment in Daily Activities)
    Description
    Time Frame baseline, Week1 and Week 2

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title
    Arm/Group Description
    4. Secondary Outcome
    Title Change From Baseline in Individual Scores for Local Nasal Findings (Rhinoscopic Findings)
    Description
    Time Frame baseline, Week1 and Week 2

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title
    Arm/Group Description
    5. Secondary Outcome
    Title Change From Baseline in Severity Score for Symptoms of Allergic Rhinitis
    Description
    Time Frame Randomization, Week1 and Week 2

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title
    Arm/Group Description
    6. Secondary Outcome
    Title Adverse Events and Adverse Drug Reactions
    Description
    Time Frame Week 2

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title
    Arm/Group Description

    Adverse Events

    Time Frame
    Adverse Event Reporting Description
    Arm/Group Title TAU-284 Placebo
    Arm/Group Description TAU-284 10mg twice daily for 2 weeks TAU-284 placebo twice daily for 2 weeks
    All Cause Mortality
    TAU-284 Placebo
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN)
    Serious Adverse Events
    TAU-284 Placebo
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/240 (0%) 0/232 (0%)
    Other (Not Including Serious) Adverse Events
    TAU-284 Placebo
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 17/240 (7.1%) 15/232 (6.5%)
    Infections and infestations
    Pharyngitis 10/240 (4.2%) 6/232 (2.6%)
    Nasopharyngitis 7/240 (2.9%) 9/232 (3.9%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    Results Point of Contact

    Name/Title Clinical Trials, Information Desk
    Organization Mitsubishi Tanabe Pharma Corporation
    Phone
    Email cti-inq-ml@ml.mt-pharma.co.jp
    Responsible Party:
    Mitsubishi Tanabe Pharma Corporation
    ClinicalTrials.gov Identifier:
    NCT01861522
    Other Study ID Numbers:
    • TAU-284-20
    First Posted:
    May 23, 2013
    Last Update Posted:
    Dec 15, 2015
    Last Verified:
    Nov 1, 2015