Dermatitis, AtopicPhase 3NCT02182570
WAL 801 CL Dry Syrup in Pediatric Atopic Dermatitis Patients
A Phase 3 study testing WAL 801 CL dry syrup in people with Dermatitis, Atopic, run by Boehringer Ingelheim.
Trial summary
The safety and efficacy of WAL 801 CL (epinastine hydrochloride) Dry Syrup in the treatment of atopic dermatitis in children was evaluated and plasma drug concentrations were measured. Read more about this study
- Who is it for?
- Ages Up to 15 years
- Conditions the study is for
- Dermatitis, Atopic
- What is being tested?
- WAL 801 CL dry syrup
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- No sites listed yet
- Study dates
- Jun 2001to Feb 2002
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 Up to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- For inclusion in this study, subjects must be pediatric atopic dermatitis patients that meet the following criteria and thus be appropriate for observation of pruritus. Diagnosis of atopic dermatitis will be conducted in accordance with the "Definition and Diagnostic Criteria of Atopic Dermatitis", issued by the Japanese Dermatological Association.
- 15 years of age or younger
- Body weight of 14 kg or more
- Outpatients
- The patient has been undergoing treatment with a "very strong" or lower-grade external steroid preparation for >= 1 week at the time informed consent is obtained
- Pruritus with "2" or higher grade at the start time of administration
Who cannot join
- Use of sustained release adrenocorticotropic hormone (Kenacort® A, Depo-medrol®, etc.), oral preparation of methotrexate, or oral preparation of ciclosporin, within 4 weeks before initial administration of the investigational product
- Oral intake, inhalation and injection of any steroid within 2 weeks before initial administration of the investigational product
- Use of any external steroid preparation at "Strongest" in any sites other than the face or scalp within 2 weeks before initial administration of the investigational product
- Undergoing phototherapy
- Undergoing specific desensitization therapy or modulation therapy
- Past history of contact dermatitis caused by external steroid preparation
Show all 11Show fewer
- Possibility of exacerbation by an external steroid preparation of infectious skin disease caused by bacteria, fungi, or virus
- Clinically significant hepatic, renal, or cardiac disease or other complications: therefore, judgement that the patient was ineligible for inclusion in this study. Patients must be excluded from the study if the patients fell under Grade 2 or more, in the MHW (Ministry of health and welfare) Adverse Reaction Severity Classification Criteria
- Past history of allergy to any drug
- Participation in any other clinical study, or history of participation in any other clinical study within 6 months before the date when the patient gave consent to participate in this study
- Judgement by the Principal Investigator or Investigator that the patient is ineligible for inclusion in this study
About this study
Official title: Phase III Open-labeled Study of WAL 801 CL Dry Syrup in Pediatric Atopic Dermatitis Patients
The safety and efficacy of WAL 801 CL (epinastine hydrochloride) Dry Syrup in the treatment of atopic dermatitis in children was evaluated and plasma drug concentrations were measured.
- Conditions
- Dermatitis, Atopic
- Being tested
- WAL 801 CL dry syrup
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WAL 801 CL dry syrupDrug
| Study group | Role | What they receive |
|---|---|---|
| WAL 801 CL | Experimental | Not described Receives: Drug: WAL 801 CL dry syrup |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall incidence of adverse events
Measured: up to 12 weeks
Occurrence of abnormal changes in laboratory measurements (haematological tests, blood biochemical tests, and urinalysis)
Measured: Baseline, weeks 4, 8 and 12
Secondary outcomes (5)
Degree of pruritus
Measured: at weeks 4, 8 and 12
Degree of rash
Measured: at weeks 4, 8 and 12
Pruritus score obtained through the itching questionnaire
Measured: at weeks 4, 8 and 12
Impression on pruritus of the patient or the parent
Measured: week 12
Plasma concentration of epinastine hydrochloride
Measured: pre-dose and 6, 12, 18, 24, 30, 36 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2014 (estimated)
- Study startJun 2001
- Primary completionFeb 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dermatitis, AtopicStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02182570
- Sponsor's protocol ID
- 262.260
- Status last verified
- Jul 2014
- First submitted
- 2 Jul 2014
- Last updated
- 14 Jul 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Open-labeled Study of WAL 801 CL Dry Syrup in Pediatric Atopic Dermatitis Patients
- ClinicalTrials.gov ID
- NCT02182570
- Acronym / sponsor ID
- 262.260
- Conditions
- Dermatitis, Atopic
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Jun 2001
- Primary completion
- Feb 2002 (actual)
- First posted
- 8 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The safety and efficacy of WAL 801 CL (epinastine hydrochloride) Dry Syrup in the treatment of atopic dermatitis in children was evaluated and plasma drug concentrations were measured.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| WAL 801 CL | Experimental | Drug: WAL 801 CL dry syrup |
Who may qualify
- Ages
- Up to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- For inclusion in this study, subjects must be pediatric atopic dermatitis patients that meet the following criteria and thus be appropriate for observation of pruritus. Diagnosis of atopic dermatitis will be conducted in accordance with the "Definition and Diagnostic Criteria of Atopic Dermatitis", issued by the Japanese Dermatological Association.
- 15 years of age or younger
- Body weight of 14 kg or more
- Outpatients
- The patient has been undergoing treatment with a "very strong" or lower-grade external steroid preparation for >= 1 week at the time informed consent is obtained
Key exclusion criteria (11 listed)
- Use of sustained release adrenocorticotropic hormone (Kenacort® A, Depo-medrol®, etc.), oral preparation of methotrexate, or oral preparation of ciclosporin, within 4 weeks before initial administration of the investigational product
- Oral intake, inhalation and injection of any steroid within 2 weeks before initial administration of the investigational product
- Use of any external steroid preparation at "Strongest" in any sites other than the face or scalp within 2 weeks before initial administration of the investigational product
- Undergoing phototherapy
- Undergoing specific desensitization therapy or modulation therapy
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 |
|---|---|---|
| WAL 801 CL dry syrup | Drug | WAL 801 CL |
Primary outcome
Overall incidence of adverse events
Time frame: up to 12 weeks
Occurrence of abnormal changes in laboratory measurements (haematological tests, blood biochemical tests, and urinalysis)
Time frame: Baseline, weeks 4, 8 and 12
5 secondary outcomes
Degree of pruritus
Time frame: at weeks 4, 8 and 12
Degree of rash
Time frame: at weeks 4, 8 and 12
Pruritus score obtained through the itching questionnaire
Time frame: at weeks 4, 8 and 12
Impression on pruritus of the patient or the parent
Time frame: week 12
Plasma concentration of epinastine hydrochloride
Time frame: pre-dose and 6, 12, 18, 24, 30, 36 hours post-dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing WAL 801 CL dry syrup in people with Dermatitis, Atopic, run by Boehringer Ingelheim.
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 6 inclusion and 11 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 14 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Overall incidence of adverse events (time frame: up to 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Jul 2014.