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A Confirmatory Study of TAU-284 in Pediatric Patients With Atopic Dermatitis

Sponsor
Mitsubishi Tanabe Pharma Corporation (Industry)
Overall Status
Completed
CT.gov ID
NCT01840605
Collaborator
(none)
303
Enrollment
1
Location
2
Arms
8
Duration (Months)
37.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The objective of this study is to verify the non-inferiority of TAU-284 to ketotifen fumarate dry syrup in the change in the severity of pruritus after the treatment period.

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

Detailed Description

This is a randomized, double-blind, parallel-group comparative study to demonstrate the noninferiority of TAU-284 to ketotifen fumarate in pediatric patients with atopic dermatitis, as assessed by the primary endpoint of the change from baseline in pruritus score after 2-week treatment with TAU-284 (20 mg/day) or ketotifen fumarate dry syrup (2 g/day); and to investigate the safety, and plasma concentrations of TAU-284.

Study Design

Study Type:
Interventional
Actual Enrollment :
303 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 Atopic Dermatitis (Ketotifen Fumarate-controlled, Double-blind, Comparative Study)
Study Start Date :
Mar 1, 2013
Actual Primary Completion Date :
Nov 1, 2013
Actual Study Completion Date :
Nov 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Experimental: TAU-284

Two TAU-284 5mg tablets and one ketotifen fumarate dry syrup 1g placebo will be taken orally twice a day, once after breakfast and once before bed.

Drug: Bepotastine besilate
Two TAU-284 5mg tablets and one ketotifen fumarate dry syrup 1g placebo will be taken orally twice a day
Other Names:
  • TALION 5mg tablets

    		•
    Active Comparator: ketotifen fumarate

    Two TAU-284 5mg placebo tablets and one ketotifen fumarate dry syrup 1g will be taken orally twice a day, once after breakfast and once before bed.

    Drug: ketotifen fumarate
    Two TAU-284 5 mg placebo tablets and one ketotifen fumarate dry syrup 1g will be taken orally twice a day
    Other Names:
  • ketotifen fumarate dry syrup

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change From Baseline in Pruritus Score [Baseline and 2 weeks]

      The pruritus symptoms score were rated on 5-point scale ranging from 0 (none) to 4 (severe).

    Secondary Outcome Measures

    1. Change From Baseline in Pruritus Score [Baseline and 1 weeks]

      The pruritus symptoms score were rated on 5-point scale ranging from 0 (none) to 4 (severe).

    2. Severity of Atopic Dermatitis at 2 Weeks (Change From Baseline) [Baseline and 2 weeks]

      Severity score were rated on 5-point scale ranging from 0 (none) to 4 (severe).

    3. Percentage of Participants With Patient Impression Score (Reporting Excellent or Very Well Improved in Pruritus) [Week 2]

      Patient impression score were rated on 5-point scale ranging from 0 to 4 (4 excellent, 3 very well, 2 well, 1fair, 0 poor).

    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 giving assent and whose legal guardian giving informed consent

    • Outpatients

    • Patients diagnosed as atopic dermatitis

    • Patients who require the treatment with topical corticosteroid on areas other than face, head and neck

    • Patients whose diaries can be properly maintained

    • Patients who have 2 grades or more pruritus score

    Exclusion Criteria:

    • Patients with bronchial asthma who require concomitant use of the corticosteroid

    • Patients who have been undergoing specific desensitization therapy or nonspecific immunomodulation therapy or phototherapy

    • Patients with current or previous history of drug hypersensitivity

    • Patients who have been treated with Bepotastine besilate in the past

    • Patients who have; a skin infection, or with zooparasite such as scabies and pediculosis; eczematous otitis externa with perforation in the eardrum; dermal ulcer, or profound heat burn or frostbite of the severity higher than the grade 2; on areas where topical corticosteroid is applied

    • Patients who have spastic disease such as epilepsy

    • Patients who concurrently have renal function abnormalities that may cause safety problems

    • Patients who do not give consent to use birth control

    • Pregnant patients, at risk of pregnancy or breastfeeding

    • Patients who had participated in any clinical trial in the last 12 weeks

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Medical Corporation Kojinkai Asanuma Dermatology Clinic Hokkaido Japan

    Sponsors and Collaborators

    • Mitsubishi Tanabe Pharma Corporation

    Investigators

    • Study Director: MAKOTO KAWASHIMA, Tokyo Women's Medical University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mitsubishi Tanabe Pharma Corporation
    ClinicalTrials.gov Identifier:
    NCT01840605
    Other Study ID Numbers:
    • TAU-284-19
    First Posted:
    Apr 26, 2013
    Last Update Posted:
    May 25, 2018
    Last Verified:
    Sep 1, 2017
    Additional relevant MeSH terms:
    Dermatitis, Atopic
    Dermatitis
    Ketotifen
    Bepotastine besilate

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title TAU-284 Ketotifen Fumarate
    Arm/Group Description TAU-284 10mg twice daily for 2 weeks Ketotifen fumarate dry syrup 1g twice daily for 2 weeks
    Period Title: Overall Study
    STARTED 151 152
    COMPLETED 149 150
    NOT COMPLETED 2 2

    Baseline Characteristics

    Arm/Group Title TAU-284 Ketotifen Fumarate Total
    Arm/Group Description TAU-284 10mg twice daily for 2 weeks Ketotifen fumarate dry syrup 1g twice daily for 2 weeks Total of all reporting groups
    Overall Participants 151 152 303
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    10.2
    (2.3)
    10.4
    (2.5)
    10.3
    (2.4)
    Sex: Female, Male (Count of Participants)
    Female
    79
    52.3%
    62
    40.8%
    141
    46.5%
    Male
    72
    47.7%
    90
    59.2%
    162
    53.5%

    Outcome Measures

    1. Primary Outcome
    Title Change From Baseline in Pruritus Score
    Description The pruritus symptoms score were rated on 5-point scale ranging from 0 (none) to 4 (severe).
    Time Frame Baseline and 2 weeks

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title TAU-284 Ketotifen Fumarate
    Arm/Group Description TAU-284 10mg twice daily for 2 weeks Ketotifen fumarate dry syrup 1g twice daily for 2 weeks
    Measure Participants 151 152
    Least Squares Mean (Standard Error) [units on a scale]
    -0.669
    (0.058)
    -0.638
    (0.058)
    2. Secondary Outcome
    Title Change From Baseline in Pruritus Score
    Description The pruritus symptoms score were rated on 5-point scale ranging from 0 (none) to 4 (severe).
    Time Frame Baseline and 1 weeks

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title TAU-284 Ketotifen Fumarate
    Arm/Group Description TAU-284 10mg twice daily for 2 weeks Ketotifen fumarate dry syrup 1g twice daily for 2 weeks
    Measure Participants 151 152
    Least Squares Mean (Standard Error) [units on a scale]
    -0.425
    (0.047)
    -0.510
    (0.047)
    3. Secondary Outcome
    Title Severity of Atopic Dermatitis at 2 Weeks (Change From Baseline)
    Description Severity score were rated on 5-point scale ranging from 0 (none) to 4 (severe).
    Time Frame Baseline and 2 weeks

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title TAU-284 Ketotifen Fumarate
    Arm/Group Description TAU-284 10mg twice daily for 2 weeks Ketotifen fumarate dry syrup 1g twice daily for 2 weeks
    Measure Participants 151 152
    Least Squares Mean (Standard Error) [units on a scale]
    -0.8
    (0.0)
    -0.7
    (0.0)
    4. Secondary Outcome
    Title Percentage of Participants With Patient Impression Score (Reporting Excellent or Very Well Improved in Pruritus)
    Description Patient impression score were rated on 5-point scale ranging from 0 to 4 (4 excellent, 3 very well, 2 well, 1fair, 0 poor).
    Time Frame Week 2

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title TAU-284 Ketotifen Fumarate
    Arm/Group Description TAU-284 10mg twice daily for 2 weeks Ketotifen fumarate dry syrup 1g twice daily for 2 weeks
    Measure Participants 151 152
    Number (95% Confidence Interval) [percentage of participants]
    65.6
    43.4%
    65.1
    42.8%

    Adverse Events

    Time Frame
    Adverse Event Reporting Description
    Arm/Group Title TAU-284 Ketotifen Fumarate
    Arm/Group Description TAU-284 10mg twice daily for 2 weeks Ketotifen fumarate dry syrup 1g twice daily for 2 weeks
    All Cause Mortality
    TAU-284 Ketotifen Fumarate
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN)
    Serious Adverse Events
    TAU-284 Ketotifen Fumarate
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/151 (0%) 0/152 (0%)
    Other (Not Including Serious) Adverse Events
    TAU-284 Ketotifen Fumarate
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 6/151 (4%) 11/152 (7.2%)
    Infections and infestations
    Nasopharyngitis 3/151 (2%) 6/152 (3.9%)
    Nervous system disorders
    Somnolence 3/151 (2%) 6/152 (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:
    NCT01840605
    Other Study ID Numbers:
    • TAU-284-19
    First Posted:
    Apr 26, 2013
    Last Update Posted:
    May 25, 2018
    Last Verified:
    Sep 1, 2017