Study Of Cutaneous Disease Accompanied With Pruritus In Pediatrics

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Primary Purpose

Status

Completed

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

Cetirizine Dry Syrup

About this trial

This is an interventional treatment trial for Pruritus focused on measuring cetirizine, various type of cutaneous disease accompanied with Pruritus, pediatrics

Eligibility Criteria

2 Years - 14 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

GSK Investigational Site

Outcomes

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

Full Information

NCT ID

NCT00257582

First Posted

November 21, 2005

Last Updated

May 3, 2013

Sponsor

GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT00257582

Brief Title

Study Of Cutaneous Disease Accompanied With Pruritus In Pediatrics

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2013

Overall Recruitment Status

Completed

Study Start Date

August 2005 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

GlaxoSmithKline

4. Oversight

Data Monitoring Committee

No

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pruritus

Keywords

cetirizine, various type of cutaneous disease accompanied with Pruritus, pediatrics

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

60 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Cetirizine Dry Syrup

Primary Outcome Measure Information:

Title

To assess the safety

Secondary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

2 Years

Maximum Age & Unit of Time

14 Years

Accepts Healthy Volunteers

No

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

GSK Clinical Trials

Organizational Affiliation

GlaxoSmithKline

Official's Role

Study Director

Facility Information:

Facility Name

GSK Investigational Site

Pruritus

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial