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Safety Study To Assess Growth In Pre-Pubertal Children Treated With An Investigational Nasal Spray For Allergic Rhinitis - Article


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Seasonal Affective Disorder

SAD 




Clinical Trial: Safety Study To Assess Growth In Pre-Pubertal Children Treated With An Investigational Nasal Spray For Allergic Rhinitis

This study is currently recruiting patients.

Sponsored by: GlaxoSmithKline
Information provided by: GlaxoSmithKline

Purpose

The primary objective of the study is to determine any effect on growth following use of a nasal spray treatment versus a placebo nasal spray in children with seasonal allergic rhinitis (SAR) and/or perennial allergic rhinitis (PAR).

Condition Treatment or Intervention Phase
Hayfever
Allergic Rhinitis
Seasonal rhinitis
Perennial Rhinitis
Non-Seasonal rhinitis
 Drug: Investigational nasal spray for allergic rhinitis
Phase III

MedlinePlus related topics:  Allergy;   Common Cold;   Nose Disorders;   Respiratory Diseases

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety Study

Eligibility

Ages Eligible for Study:  6 Years   -   12 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion criteria:

  • Pre-menarcheal female subjects (ages 6 to 11).
  • Male subjects (ages 6 to 12)
  • Tanner Stage 1
  • History of SAR (Seasonal Allergic Rhinitis) or PAR (Perennial Allergic Rhinitis) of at least one year with either a current level of allergic rhinitis symptoms that warrants treatment and/or expected symptoms during a majority of the study period.
  • Positive skin test to an appropriate seasonal or perennial allergen.

Exclusion criteria:

  • History of abnormal growth or gross malnutrition.
  • clinically significant laboratory abnormality.
  • History of any condition that may have substantially affected growth.
  • Historical or current evidence of clinically significant, uncontrolled disease of any body system.
  • Any asthma other than mild, intermittent asthma controlled by short-acting, beta-agonists.
  • Recent major surgery and/or trauma to the legs.
  • History of adrenal insufficiency.
  • Current or prior treatment with any medication that may have a potential for an ongoing effect on linear growth.
  • Use of corticosteroids, by any route, within 4 weeks prior to Visit 1.
  • Any nasal condition or deformity that would impair nasal breathing or deposition of medication.
  • Physical impairment that would affect the subject's ability to participate in the study.

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00109486


Denmark
      Randers,  Denmark; Recruiting
Study Coordinator  011004587 100808 

More Information

Study ID Numbers:  101747
Record last reviewed:  April 2005
Last Updated:  April 28, 2005
Record first received:  April 28, 2005
ClinicalTrials.gov Identifier:  NCT00109486
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-05-03


Source: ClinicalTrials.gov
Cache Date: May 4, 2005

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November 23, 2009



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