Study Of Cutaneous Disease Accompanied With Pruritus In Pediatrics - Full Text View

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

MedlinePlus related topics:

Children's Health Itching

ChemIDplus related topics:

Cetirizine Cetirizine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Official Title:	Long-Term Study of Cetirizine Dry Syrup in Children Suffering From Various Type of Cutaneous Disease Accompanied With Pruritus.

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:	July 2005

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

Locations


Japan
	GSK Clinical Trials Call Center
	Hokkaido_1, Japan, 066
	GSK Clinical Trials Call Center
	Hokkaido_2, Japan, 060
	GSK Clinical Trials Call Center
	Hokkaido_3, Japan, 061
	GSK Clinical Trials Call Center
	Hokkaido_14, Japan, 093
	GSK Clinical Trials Call Center
	Saitama_15, Japan, 359
	GSK Clinical Trials Call Center
	Tokyo_16, Japan, 166
	GSK Clinical Trials Call Center
	Tokyo_17, Japan, 157
	GSK Clinical Trials Call Center
	Tokyo_18, Japan, 158
	GSK Clinical Trials Call Center
	Fukuoka_23, Japan, 814
	GSK Clinical Trials Call Center
	Fukuoka_24, Japan, 819
	GSK Clinical Trials Call Center
	Fukuoka_25, Japan, 819
	GSK Clinical Trials Call Center
	Fukuoka_22, Japan, 813
	GSK Clinical Trials Call Center
	Hokkaido_5, Japan, 066
	GSK Clinical Trials Call Center
	Hokkaido_6, Japan, 062
	GSK Clinical Trials Call Center
	Hokkaido_8, Japan, 003
	GSK Clinical Trials Call Center
	Hokkaido_11, Japan, 061
	GSK Clinical Trials Call Center
	Hokkaido_12, Japan, 079
	GSK Clinical Trials Call Center
	Hokkaido_13, Japan, 090
	GSK Clinical Trials Call Center
	Kanagawa_19, Japan, 245
	GSK Clinical Trials Call Center
	Fukuoka_20, Japan, 814
	GSK Clinical Trials Call Center
	Fukuoka_21, Japan, 814
	GSK Clinical Trials Call Center
	Hokkaido_4, Japan, 069

Sponsors and Collaborators

GlaxoSmithKline

UCB

Investigators


Study Director:	GSK Clinical Trials, MD	GlaxoSmithKline

More Information

Study ID Numbers:	104915, RPCE04E1703/A00389
First Received:	November 21, 2005
Last Updated:	July 31, 2007
ClinicalTrials.gov Identifier:	NCT00257582
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by GlaxoSmithKline:

various type of cutaneous disease accompanied with Pruritus

pediatrics

cetirizine

Study placed in the following topic categories:

Pruritus

Signs and Symptoms

Skin Diseases

Histamine phosphate

Cetirizine

Histamine

Additional relevant MeSH terms:

Skin Manifestations

Neurotransmitter Agents

Molecular Mechanisms of Pharmacological Action

Histamine Antagonists

Therapeutic Uses

Physiological Effects of Drugs

Histamine Agents

Histamine H1 Antagonists

Anti-Allergic Agents

Histamine H1 Antagonists, Non-Sedating

Pharmacologic Actions

ClinicalTrials.gov processed this record on September 19, 2008

Sponsors and Collaborators:	GlaxoSmithKline UCB
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00257582