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Study Of Perennial Allergic Rhinitis In Pediatrics

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ClinicalTrials.gov Identifier: NCT00253058
Recruitment Status : Completed
First Posted : November 15, 2005
Last Update Posted : May 6, 2013
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Description
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Brief Summary:
To verify of cetirizine dry syrup to ketotifen dry syrup in the change of total nasal symptom score (TNSS) over the total treatment period from the score of the baseline assessment period

Condition or disease Intervention/treatment Phase
Rhinitis, Allergic, Perennial Drug: Cetirizine Dry Syrup Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 286 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Evaluation of the Efficacy and Safety of Cetirizine Dry Syrup in Children -Suffering From Perennial Allergic Rhinitis-
Study Start Date : July 2005

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U.S. FDA Resources

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. change in the total nasal symptom score (TNSS)

Secondary Outcome Measures :
  1. - Individual daily nasal symptom score - Investigator global improvement/patient global improvement - Nasal findings - Cetirizine serum concentrations - Adverse events

Eligibility Criteria
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Ages Eligible for Study:   3 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Children with perennial allergic rhinitis.
  • Giving informed consent.
  • Children with a positive response to specific IgE antibody test.
  • Children assessed as positive in the nasal eosinophil count.
  • Children whose severity score of nasal symptom is 4 or higher.

Exclusion criteria:

  • have spastic disease such as epilepsy
  • have a history of drug hypersensitivity
  • are pregnant, lactating or possibly pregnant female Children
  • are sensitive to pollen as a duplicate allergen and whose treatment periods are thought in the pollen dispersion periods
  • have vasomotor rhinitis and eosinophilic rhinitis
  • have asthma that requires the treatment with corticosteroid
  • have inappropriate complication of nasal disorder that may influence on the evaluation of the study drugs
  • have complicated with atopic dermatitis or urticaria that requires the treatment with antihistamine preparation
  • have started specific desensitization treatment or nonspecific modulation treatment but who have not reached the maintenance level of treatment
  • have received surgical treatment for reduction and modulation of nasal mucosa
  • redintegration therapy of nasal cavity to improve the degree of nasal airway
  • surgical operation to improve rhinorrhea.
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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): NCT00253058


Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00253058     History of Changes
Other Study ID Numbers: 104912
First Posted: November 15, 2005    Key Record Dates
Last Update Posted: May 6, 2013
Last Verified: May 2013

Keywords provided by GlaxoSmithKline:
Allergic
pediatric
Rhinitis
Perennial

Additional relevant MeSH terms:
Rhinitis
Rhinitis, Allergic
Rhinitis, Allergic, Perennial
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
 Immune System Diseases
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