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Perennial Allergic Rhinitis In Pediatric Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00257595
Recruitment Status : Completed
First Posted : November 23, 2005
Last Update Posted : May 6, 2013
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Tracking Information
First Submitted Date  ICMJE November 21, 2005
First Posted Date  ICMJE November 23, 2005
Last Update Posted Date May 6, 2013
Study Start Date  ICMJE August 2005
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: November 22, 2005)
safety
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00257595 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 17, 2006)
Total Nasal Symptom Score (TNSS) Individual nasal symptom score total score of 4 individual daily symptom scores Investigator global improvement rating
Original Secondary Outcome Measures  ICMJE
 (submitted: November 22, 2005)
  • Total Nasal Symptom Score (TNSS)
  • Individual nasal symptom score
  • Total score of 4 individual daily symptom scores
  • Investigator global improvement rating
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Perennial Allergic Rhinitis In Pediatric Subjects
Official Title  ICMJE Long-term Study of Cetirizine Dry Syrup in Children. Suffering From Perennial Allergic Rhinitis.
Brief Summary To assess the safety of long-term use of cetirizine dry syrup in children with perennial allergic rhinitis.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Rhinitis, Allergic, Perennial
Intervention  ICMJE Drug: Cetirizine Dry Syrup
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: November 22, 2005)
30
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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 a history of drug hypersensitivity.
  • are pregnant, lactating or possibly pregnant female children.
  • Sensitivity 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.
  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Years to 14 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries Japan
 
Administrative Information
NCT Number  ICMJE NCT00257595
Other Study ID Numbers  ICMJE 104914
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party GlaxoSmithKline
Study Sponsor  ICMJE GlaxoSmithKline
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: GSK Clinical Trials GlaxoSmithKline
PRS Account GlaxoSmithKline
Verification Date May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP