DermatitisPhase 3NCT01840605
A Confirmatory Study of TAU-284 in Pediatric Patients With Atopic Dermatitis
A Phase 3 study testing Bepotastine besilate and ketotifen fumarate in people with Dermatitis and Atopic, run by Tanabe Pharma Corporation at 1 site in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 15 years
- Conditions the study is for
- Dermatitis, Atopic
- What is being tested?
- Bepotastine besilate and ketotifen fumarate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 303 participants
- Where
- 1 siteJapan
- Study dates
- Mar 2013to Nov 2013
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Confirmatory Study of TAU-284 in Pediatric Patients With Atopic Dermatitis (Ketotifen Fumarate-controlled, Double-blind, Comparative Study)
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.
Read the 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.
- Conditions
- Dermatitis, Atopic
- Being tested
- Bepotastine besilate, ketotifen fumarate
- Medical subject headings
- Dermatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bepotastine besilateDrug
Also called TALION 5mg tablets
Two TAU-284 5mg tablets and one ketotifen fumarate dry syrup 1g placebo will be taken orally twice a day
ketotifen fumarateDrug
Also called ketotifen fumarate dry syrup
Two TAU-284 5 mg placebo tablets and one ketotifen fumarate dry syrup 1g will be taken orally twice a day
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: ketotifen fumarate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Pruritus Score
The pruritus symptoms score were rated on 5-point scale ranging from 0 (none) to 4 (severe).
Measured: Baseline and 2 weeks
Secondary outcomes (3)
Change From Baseline in Pruritus Score
The pruritus symptoms score were rated on 5-point scale ranging from 0 (none) to 4 (severe).
Measured: Baseline and 1 weeks
Severity of Atopic Dermatitis at 2 Weeks (Change From Baseline)
Severity score were rated on 5-point scale ranging from 0 (none) to 4 (severe).
Measured: Baseline and 2 weeks
Percentage of Participants With Patient Impression Score (Reporting Excellent or Very Well Improved in Pruritus)
Patient impression score were rated on 5-point scale ranging from 0 to 4 (4 excellent, 3 very well, 2 well, 1fair, 0 poor).
Measured: Week 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2013 (estimated)
- Study startMar 2013
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DermatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 303 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanabe Pharma Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MAKOTO KAWASHIMA, Study director, Tokyo Women's Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01840605
- Sponsor's protocol ID
- TAU-284-19
- Status last verified
- Dec 2025
- First submitted
- 23 Apr 2013
- Last updated
- 8 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Confirmatory Study of TAU-284 in Pediatric Patients With Atopic Dermatitis (Ketotifen Fumarate-controlled, Double-blind, Comparative Study)
- ClinicalTrials.gov ID
- NCT01840605
- Acronym / sponsor ID
- TAU-284-19
- Conditions
- Dermatitis, Atopic
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 303 participants (actual)
- Lead sponsor
- Tanabe Pharma CorporationIndustry (pharma, biotech, devices)
- Study start
- Mar 2013
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 26 Apr 2013 (estimated)
- Results
- Posted 16 Oct 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TAU-284 | Experimental | Drug: Bepotastine besilateTwo 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. |
| ketotifen fumarate | Active comparator | Drug: ketotifen fumarateTwo 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. |
Who may qualify
- Ages
- 7 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bepotastine besilateAlso: TALION 5mg tabletsTwo TAU-284 5mg tablets and one ketotifen fumarate dry syrup 1g placebo will be taken orally twice a day | Drug | TAU-284 |
| ketotifen fumarateAlso: ketotifen fumarate dry syrupTwo TAU-284 5 mg placebo tablets and one ketotifen fumarate dry syrup 1g will be taken orally twice a day | Drug | ketotifen fumarate |
Primary outcome
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).
3 secondary outcomes
Change From Baseline in Pruritus Score
Time frame: Baseline and 1 weeks
Severity of Atopic Dermatitis at 2 Weeks (Change From Baseline)
Time frame: Baseline and 2 weeks
Percentage of Participants With Patient Impression Score (Reporting Excellent or Very Well Improved in Pruritus)
Time frame: Week 2
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publicationKawashima 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MAKOTO KAWASHIMA study director
Tokyo Women's Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Bepotastine besilate and ketotifen fumarate in people with Dermatitis and Atopic, run by Tanabe Pharma Corporation at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Oct 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Pruritus Score (time frame: Baseline and 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01840605, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2026.