Study Of Cutaneous Disease Accompanied With Pruritus In Pediatrics

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00257582
First received: November 21, 2005
Last updated: May 3, 2013
Last verified: May 2013
  Purpose

To assess the safety of long-term use of cetirizine dry syrup in children with various type of cutaneous disease accompanied on pruritus.


Condition Intervention Phase
Pruritus
Drug: Cetirizine Dry Syrup
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Long-term Study of Cetirizine Dry Syrup in Children Suffering From Various Type of Cutaneous Disease Accompanied With Pruritus.

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • To assess the safety

Secondary Outcome Measures:
  • -severity of pruritus -total pruritus score -daily main prurutus score -Severity of eruption -Patient global Improvement rating -Body temperature -Adverse events -Cetirizine serum concentrations

Estimated Enrollment: 60
Study Start Date: August 2005
Intervention Details:
    Drug: Cetirizine Dry Syrup
    Other Name: Cetirizine Dry Syrup
  Eligibility

Ages Eligible for Study:   2 Years to 14 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Chronic urticaria
  • Eczema & dermatitis group
  • Atopic dermatitis
  • Prurigo group: Acute prurigo, Prurigo subacuta, Chronic prurigo
  • Pruritus cutaneous: Systemic pruritus cutaneous, Topical pruritus cutaneous
  • Giving informed consent
  • Children who have 2 grades or more pruritus score when assessed by the investigator or sub-investigator with the criteria for the diurnal or nocturnal pruritus score in the patient diary.
  • Children with a pruritus severity of "2.Mild" or severer on the first day of the treatment period.

Exclusion criteria:

  • have a history of drug hypersensitivity
  • are pregnant, lactating or possibly pregnant female children.
  • have asthma that requires the treatment with corticosteroid.
  • cannot avoid the use of external steroid classified into "strong", "strongest" or "very strong".
  • 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00257582

Locations
Spain
GSK Investigational Site
Unknown, Spain
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00257582     History of Changes
Other Study ID Numbers: 104915
Study First Received: November 21, 2005
Last Updated: May 3, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by GlaxoSmithKline:
cetirizine
various type of cutaneous disease accompanied with Pruritus
pediatrics

Additional relevant MeSH terms:
Pruritus
Skin Diseases
Skin Manifestations
Signs and Symptoms
Cetirizine
Anti-Allergic Agents
Therapeutic Uses
Pharmacologic Actions
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 23, 2014