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
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, see Learn About Clinical Studies.

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 September 18, 2014