NCT01840605

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
303

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Mar 2013

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 23, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 26, 2013

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
2 years until next milestone

Results Posted

Study results publicly available

October 16, 2015

Completed
Last Updated

January 8, 2026

Status Verified

December 1, 2025

Enrollment Period

8 months

First QC Date

April 23, 2013

Results QC Date

September 17, 2015

Last Update Submit

December 15, 2025

Conditions

DermatitisAtopic

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline in Pruritus Score

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

    Baseline and 2 weeks

Secondary Outcomes (3)

  • Change From Baseline in Pruritus Score

    Baseline and 1 weeks

  • Severity of Atopic Dermatitis at 2 Weeks (Change From Baseline)

    Baseline and 2 weeks

  • Percentage of Participants With Patient Impression Score (Reporting Excellent or Very Well Improved in Pruritus)

    Week 2

Study Arms (2)

TAU-284

EXPERIMENTAL

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

ketotifen fumarate

ACTIVE COMPARATOR

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

Interventions

Bepotastine besilateDRUG

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

Also known as: TALION 5mg tablets
TAU-284
ketotifen fumarateDRUG

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

Also known as: ketotifen fumarate dry syrup
ketotifen fumarate

Eligibility Criteria

Age7 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical Corporation Kojinkai Asanuma Dermatology Clinic

Hokkaido, Japan

Location

Related Publications (1)

  • 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

    RESULT

MeSH Terms

Conditions

Dermatitis

Interventions

bepotastine besilateKetotifen

Condition Hierarchy (Ancestors)

Skin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

ThiophenesSulfur CompoundsOrganic ChemicalsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Results Point of Contact

Title
Clinical Trials, Information Desk
Organization
Tanabe Pharma Corporation
cti-inq-ml.JP@ml.tanabe-pharma.com

Study Officials

  • MAKOTO KAWASHIMA

    Tokyo Women's Medical University

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 23, 2013

First Posted

April 26, 2013

Study Start

March 1, 2013

Primary Completion

November 1, 2013

Study Completion

November 1, 2013

Last Updated

January 8, 2026

Results First Posted

October 16, 2015

Record last verified: 2025-12

Locations

JP(1)