Study Of Cutaneous Disease Accompanied With Pruritus In Pediatrics

Pruritus Clinical Trial

Official title:

Long-term Study of Cetirizine Dry Syrup in Children Suffering From Various Type of Cutaneous Disease Accompanied With Pruritus.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00257582
• Other study ID #: 104915
• Status: Completed
• Phase: Phase 3
• First received: November 21, 2005
• Last updated: May 3, 2013
• Start date: August 2005

Study information

• Verified date: May 2013
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 14 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pruritus

Intervention

Drug:
• Cetirizine Dry Syrup

Locations

Country	Name	City	State
Spain	GSK Investigational Site	Unknown

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the safety
Secondary	-severity of pruritus -total pruritus score -daily main prurutus score -Severity of eruption -Patient global Improvement rating -Body temperature -Adverse events -Cetirizine serum concentrations