Text Size

Study Of Cutaneous Disease Accompanied With Pruritus In Pediatrics

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00257582
First received: November 21, 2005
Last updated: October 5, 2010
Last verified: October 2010
History of Changes

November 21, 2005
October 5, 2010
August 2005
March 2006   (final data collection date for primary outcome measure)
To assess the safety
Safety
Complete list of historical versions of study NCT00257582 on ClinicalTrials.gov Archive Site
-severity of pruritus -total pruritus score -daily main prurutus score -Severity of eruption -Patient global Improvement rating -Body temperature -Adverse events -Cetirizine serum concentrations
  • - severity of pruritus
  • - total pruritus score
  • - daily main pruritus score
  • - Severity of eruption
  • - Patient global improvement rating
  • - Body temperature
  • - Adverse events
  • - Cetirizine serum concentrations
 
 
 
Study Of Cutaneous Disease Accompanied With Pruritus In Pediatrics
Long-term Study of Cetirizine Dry Syrup in Children Suffering From Various Type of Cutaneous Disease Accompanied With Pruritus.

To assess the safety of long-term use of cetirizine dry syrup in children with various type of cutaneous disease accompanied on pruritus.
 
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Cutaneous Disease
  • Pruritus
Drug: Cetirizine Dry Syrup
Other Name: Cetirizine Dry Syrup
 
 

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
March 2006
March 2006   (final data collection date for primary outcome measure)

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.
Both
2 Years to 14 Years
No
Contact information is only displayed when the study is recruiting subjects
 
 
NCT00257582
104915, RPCE04E1703/A00389
 
Study Director, GSK
GlaxoSmithKline
 
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
GlaxoSmithKline
October 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP