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Study Of Cutaneous Disease Accompanied With Pruritus In Pediatrics

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ClinicalTrials.gov Identifier: NCT00257582
Recruitment Status : Completed
First Posted : November 23, 2005
Last Update Posted : May 6, 2013
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

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.

Condition or disease Intervention/treatment Phase
Pruritus Drug: Cetirizine Dry Syrup Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (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.
Study Start Date : August 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Itching
U.S. FDA Resources




Primary Outcome Measures :
  1. To assess the safety

Secondary Outcome Measures :
  1. -severity of pruritus -total pruritus score -daily main prurutus score -Severity of eruption -Patient global Improvement rating -Body temperature -Adverse events -Cetirizine serum concentrations


Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00257582


Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00257582     History of Changes
Other Study ID Numbers: 104915
First Posted: November 23, 2005    Key Record Dates
Last Update Posted: May 6, 2013
Last Verified: May 2013

Keywords provided by GlaxoSmithKline:
cetirizine
various type of cutaneous disease accompanied with Pruritus
pediatrics

Additional relevant MeSH terms:
Pruritus
Skin Diseases
Skin Manifestations
Signs and Symptoms
Cetirizine
Anti-Allergic Agents
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs