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Study of GW685698X In Patients With Seasonal Allergic Rhinitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00363740
First received: August 11, 2006
Last updated: May 31, 2012
Last verified: January 2011
History of Changes

August 11, 2006
May 31, 2012
February 2005
April 2005   (final data collection date for primary outcome measure)
Mean change from baseline over the entire treatment period in three total nasal symptom scores.
Same as current
Complete list of historical versions of study NCT00363740 on ClinicalTrials.gov Archive Site
  • Mean change from baseline over the entire treatment period in four total nasal symptom scores.
  • Mean change from baseline over the entire treatment period in individual total nasal symptom scores.
Same as current
 
 
 
Study of GW685698X In Patients With Seasonal Allergic Rhinitis
Clinical Evaluation of GW685698 for Seasonal Allergic Rhinitis -A Placebo-controlled Study to Determine the Non-inferiority of GW685698 Over Fluticasone Propionate Using a Double-blind Manner-

This study was designed to compare the efficacy and safety of an investigational nasal spray compared with placebo nasal spray and commonly used drug in the treatment of seasonal allergic rhinitis. Allergic rhinitis is an inflammatory disorder of the upper airway that occurs following allergen exposure. The focus of this study, seasonal allergic rhinitis (SAR), is one type of allergic rhinitis that is triggered by the pollen from trees, grasses, and weeds. Typical symptoms are sneezing, nasal congestion and pruritus, rhinorrhea, and pruritic, watery, red eyes.
 
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Rhinitis, Allergic, Seasonal
  • Seasonal Allergic Rhinitis
Drug: GW685698X Aqueous Nasal Spray
Other Name: GW685698X Aqueous Nasal Spray
 
 

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
38
April 2005
April 2005   (final data collection date for primary outcome measure)

Inclusion criteria:

  • Informed consent
  • Outpatient
  • Diagnosis of seasonal allergic rhinitis with symptoms
  • Able to comply with study procedures

Exclusion Criteria:

  • Significant concomitant medical condition
  • Use of corticosteroids/allergy medications
  • Laboratory abnormality
  • Positive pregnancy test
  • Allergy to any component of investigational product
Both
16 Years and older
No
Contact information is only displayed when the study is recruiting subjects
 
 
NCT00363740
FFR100652
 
GlaxoSmithKline
GlaxoSmithKline
 
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
January 2011

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