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Study Of Atopic Dermatitis In Pediatrics

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00257569
First Posted: November 23, 2005
Last Update Posted: May 6, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
  Purpose
To verify of cetirizine dry syrup to ketotifen dry syrup in the change in the severity of pruritus of the treatment period.

Condition Intervention Phase
Dermatitis, Atopic Drug: Cetirizine Dry Syrup Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Evaluation of the Efficacy and Safety of Cetirizine Dry Syrup in Children -Suffering From Atopic Dermatitis-

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • change in the severity of pruritus

Secondary Outcome Measures:
  • -changes in the total pruritus score -daily main pruritus score -improvement of area with pruritus -patient global improvement -Cetirizine serum concentrations -Adverse events

Estimated Enrollment: 278
Study Start Date: August 2005
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   3 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Children diagnosed as atopic dermatitis
  • Giving informed consent
  • Children who have 2 grades or more pruritus score.
  • Children who require the treatment with external steroid preparation other than face and head.
  • Children with a pruritus severity of 2.
  • Mild or severe on the fist day of the treatment period.

Exclusion criteria:

  • have spastic disease such as epilepsy
  • have a history of drug hypersensitivity
  • are lactating or possibly pregnant female Children
  • have a skin infection, or with zooparasite such as scabies and pediculosis
  • cannot avoid the use of external steroid classified into strong, strongest or very strong
  • have eczematous otitis externa with perforation in the eardrum
  • have dermal ulcer, or profound heat burn or frostbite of the severity higher than the grade 2
  • have asthma that requires the treatment with corticosteroid
  • have pruritus only on face and head
  • have inappropriate complication of dermal disorder that may influence on the evaluation of the study drug
  • are undergoing specific desensitization therapy or immunomodulation therapy or phototherapy.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00257569


Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00257569     History of Changes
Other Study ID Numbers: 104913
First Submitted: November 21, 2005
First Posted: November 23, 2005
Last Update Posted: May 6, 2013
Last Verified: May 2013

Keywords provided by GlaxoSmithKline:
Atopic
Pediatric
Dermatitis

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Cetirizine
Anti-Allergic Agents
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs


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