WAL 801 CL Dry Syrup in Paediatric Atopic Dermatitis Patients

NCT02182557 | Completed Phase 3

• 1 other identifier: 262.259
• Study Type: interventional
• Target: 162
• Locations: 0 countries
• Sites: N/A

Brief Summary

Study to investigate the safety and efficacy of WAL 801 CL Dry Syrup on pruritus associated with paediatric atopic dermatitis in comparison with that of Ketotifen Fumarate Dry Syrup and to confirm the appropriateness of dosage of WAL801 Dry Syrup.

Conditions

Dermatitis, Atopic

Outcome Measures

Primary Outcomes (1)

• Degree of pruritus

  at week 4

Secondary Outcomes (6)

• Degree of pruritus

  at week 2

• Degree of rash

  at weeks 2 and 4

• Pruritus score obtained through the itching questionnaire

  at weeks 2 and 4

• Impression on pruritus of the patient or the parent

  at week 4

• Occurrence of adverse events

  up to 4 weeks

Study Arms (2)

WAL 801 CL Dry Syrup + Placebo

EXPERIMENTAL

Drug: WAL 801 CL Dry Syrup; Drug: Ketotifen Fumarate Dry Syrup placebo

Ketotifen Fumarate Dry Syrup + Placebo

ACTIVE COMPARATOR

Drug: Ketotifen Fumarate Dry Syrup; Drug: WAL 801 CL Dry Syrup placebo

Interventions

WAL 801 CL Dry Syrup DRUG

WAL 801 CL Dry Syrup + Placebo

Ketotifen Fumarate Dry Syrup DRUG

Ketotifen Fumarate Dry Syrup + Placebo

WAL 801 CL Dry Syrup placebo DRUG

Ketotifen Fumarate Dry Syrup + Placebo

Ketotifen Fumarate Dry Syrup placebo DRUG

WAL 801 CL Dry Syrup + Placebo

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
• One week or longer has passed since the patient started to use an external steroid preparation at "Strong" or lower grade, or stopped using any external steroid preparation, at the time of obtainment of consent from the patient
• Pruritus with "2" or higher grade, immediately before initial 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 "Very Strong" or higher grade 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
• Present and past history of convulsive disorder, such as epilepsy (convulsion threshold values may be lowered by the reference drug, Ketotifen Fumarate)
• 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: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• 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: January 1, 2002
• Last Updated: July 14, 2014

Record last verified: 2014-07