Study Of Cutaneous Disease Accompanied With Pruritus In Pediatrics

This study has been completed.

First Received on November 21, 2005. Last Updated on October 5, 2010 History of Changes

Sponsor:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00257582

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
Cutaneous Disease Pruritus	Drug: Cetirizine Dry Syrup	Phase III

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:

MedlinePlus related topics: Itching

Drug Information available for: Cetirizine Cetirizine hydrochloride

U.S. FDA Resources

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
Study Completion Date:	March 2006
Primary Completion Date:	March 2006 (Final data collection date for primary outcome measure)

Intervention Details:

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

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	Study Director, GSK
ClinicalTrials.gov Identifier:	NCT00257582 History of Changes
Other Study ID Numbers:	104915, RPCE04E1703/A00389
Study First Received:	November 21, 2005
Last Updated:	October 5, 2010
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by GlaxoSmithKline:

various type of cutaneous disease accompanied with Pruritus
pediatrics
cetirizine

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 February 09, 2012