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

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ClinicalTrials.gov Identifier: NCT01840605
Recruitment Status : Completed
First Posted : April 26, 2013
Results First Posted : October 16, 2015
Last Update Posted : May 25, 2018
Sponsor:
Information provided by (Responsible Party):
Mitsubishi Tanabe Pharma Corporation

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
Dermatitis Atopic 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.

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Study Type : Interventional  (Clinical Trial)
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 : March 2013
Actual Primary Completion Date : November 2013
Actual Study Completion Date : November 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Itching

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 Name: 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 Name: ketotifen fumarate dry syrup




Primary Outcome Measures :
  1. Change From Baseline in Pruritus Score [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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).



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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 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

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): NCT01840605


Locations
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Japan
Medical Corporation Kojinkai Asanuma Dermatology Clinic
Hokkaido, Japan
Sponsors and Collaborators
Mitsubishi Tanabe Pharma Corporation
Investigators
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Study Director: MAKOTO KAWASHIMA Tokyo Women's Medical University

Publications of Results:
Kawashima M; Ichimura M; Yano K; Susuta Y; Izaki H. Phase III study of bepotastine besilate in children with atopic dermatitis -A randomized, double-blind, parallel-group, comparative study with ketotifen fumarate dry syrup- Rinsho iyaku 2015 Mar;31(3):235-251

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Responsible Party: Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier: NCT01840605     History of Changes
Other Study ID Numbers: TAU-284-19
First Posted: April 26, 2013    Key Record Dates
Results First Posted: October 16, 2015
Last Update Posted: May 25, 2018
Last Verified: September 2017
Additional relevant MeSH terms:
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Dermatitis, Atopic
Dermatitis
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Ketotifen
Bepotastine besilate
Antipruritics
Dermatologic Agents
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Allergic Agents