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WAL 801 CL Dry Syrup in Pediatric Atopic Dermatitis Patients

Primary Purpose

Dermatitis, Atopic

Status

Completed

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

WAL 801 CL dry syrup

About this trial

This is an interventional treatment trial for Dermatitis, Atopic

Eligibility Criteria

undefined - 15 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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
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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

WAL 801 CL

Arm Description

Outcomes

Primary Outcome Measures

Overall incidence of adverse events

Occurrence of abnormal changes in laboratory measurements (haematological tests, blood biochemical tests, and urinalysis)

Secondary Outcome Measures

Degree of pruritus

Degree of rash

Pruritus score obtained through the itching questionnaire

Impression on pruritus of the patient or the parent

Plasma concentration of epinastine hydrochloride

Full Information

NCT ID

NCT02182570

First Posted

July 2, 2014

Last Updated

July 11, 2014

Sponsor

Boehringer Ingelheim

1. Study Identification

Unique Protocol Identification Number

NCT02182570

Brief Title

WAL 801 CL Dry Syrup in Pediatric Atopic Dermatitis Patients

Official Title

Phase III Open-labeled Study of WAL 801 CL Dry Syrup in Pediatric Atopic Dermatitis Patients

Study Type

Interventional

2. Study Status

Record Verification Date

July 2014

Overall Recruitment Status

Completed

Study Start Date

June 2001 (undefined)

Primary Completion Date

February 2002 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Boehringer Ingelheim

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dermatitis, Atopic

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

62 (Actual)

8. Arms, Groups, and Interventions

Arm Title

WAL 801 CL

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

WAL 801 CL dry syrup

Primary Outcome Measure Information:

Title

Overall incidence of adverse events

Time Frame

up to 12 weeks

Title

Occurrence of abnormal changes in laboratory measurements (haematological tests, blood biochemical tests, and urinalysis)

Time Frame

Baseline, weeks 4, 8 and 12

Secondary Outcome Measure Information:

Title

Degree of pruritus

Time Frame

at weeks 4, 8 and 12

Title

Degree of rash

Time Frame

at weeks 4, 8 and 12

Title

Pruritus score obtained through the itching questionnaire

Time Frame

at weeks 4, 8 and 12

Title

Impression on pruritus of the patient or the parent

Time Frame

week 12

Title

Plasma concentration of epinastine hydrochloride

Time Frame

pre-dose and 6, 12, 18, 24, 30, 36 hours post-dose

10. Eligibility

Sex

All

Maximum Age & Unit of Time

15 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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 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

12. IPD Sharing Statement

Links:

URL

http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/262/262.260_U03-3164.pdf

Description

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WAL 801 CL Dry Syrup in Pediatric Atopic Dermatitis Patients

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