WAL 801 CL Dry Syrup in Pediatric Atopic Dermatitis Patients

NCT02182570 | Completed Phase 3

• 1 other identifier: 262.260
• Study Type: interventional
• Target: 62
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Dermatitis, Atopic

Outcome Measures

Primary Outcomes (2)

• Overall incidence of adverse events

  up to 12 weeks

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

  Baseline, weeks 4, 8 and 12

Secondary Outcomes (5)

• Degree of pruritus

  at weeks 4, 8 and 12

• Degree of rash

  at weeks 4, 8 and 12

• Pruritus score obtained through the itching questionnaire

  at weeks 4, 8 and 12

• Impression on pruritus of the patient or the parent

  week 12

• Plasma concentration of epinastine hydrochloride

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

Study Arms (1)

WAL 801 CL

EXPERIMENTAL

Drug: WAL 801 CL dry syrup

Interventions

WAL 801 CL dry syrup DRUG

WAL 801 CL

Eligibility Criteria

• Age: Up to 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2014
• First Posted: July 8, 2014
• Study Start: June 1, 2001
• Primary Completion: February 1, 2002
• Last Updated: July 14, 2014

Record last verified: 2014-07