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Protocol Summary for FFR30002

Protocol Summary
Protocol Id: FFR30002
Secondary Ids:
Title: See Detailed Description
Phase: Phase 3
Acronym:
FDA Regulated Intervention?:
Section 801 Clinical Trial?:
Delayed Posting:
IND/IDE Protocol?: Yes
IND/IDE Grantor: CDER
IND/IDE Number: 48,647
IND/IDE Serial Number: 0037
Has Expanded Access?: None
Study Type: interventional
Oversight Authority:
  • United States: Food and Drug Administration
  • Canada: Health Canada
Collaborators:
Brief Summary: The primary objective of this study is to compare the efficacy and safety of GW685698X 100mcg once daily (QD) aqueous nasal spray with vehicle placebo nasal spray in adult and adolescent subjects (12 years of age and older) with perennial allergic rhinitis (PAR).
Detailed Description: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of Once-Daily, Intranasal Administration of GW685698X Aqueous Nasal Spray 100mcg for 4 Weeks in Adult and Adolescent Subjects (12 years of age and older) with Perennial Allergic Rhinitis (PAR)
Record Verification Date: July 2010
Status: Completed
Why Study Stopped:
Study Start Date: January 2005
Study Completion Date: May 2005
Study Completion Date Type: Actual
Primary Completion Date: May 2005
Primary Completion Date Type: Actual
Primary Purpose: Treatment
Allocation: Randomized
Masking: Double Blind
Masked Subject:
Masked Caregiver:
Masked Investigator:
Masked Assessor:
Study Design (Assignment): Parallel Assignment
Study Classification (Endpoint): Safety/Efficacy Study
Primary Outcomes:
  • Mean change from baseline over the entire treatment period in daily, reflective total nasal symptom scores. Subjects complete diaries twice daily (every 12 hours) reporting the severity of their PAR symptoms.
Secondary Outcomes:
  • Mean change from baseline over the entire treatment period in AM, pre-dose, instantaneous total nasal symptom scores. The subject completes an overall evaluation of response to therapy during the last clinic visit.
Conditions:
  • Rhinitis, Allergic, Perennial
Keywords:
  • Perennial Allergic Rhinitis
  • allergic rhinitis
  • GW685698X
Eligibility Criteria: Click to view inclusion/exclusion criteria
Gender: Both
Minimum Age: 12 Years
Maximum Age: N/A N/A
Enrollment: 288
Enrollment Type:
Healthy Volunteers?: no
Central Contact: US GSK Clinical Trials Call Center
Central Contact Phone: 877-379-3718
Central Contact Email: GSKClinicalSupportHD@gsk.com
Backup Central Contact: EU GSK Clinical Trials Call Center
Backup Central Contact Phone: +44 (0) 20 8990 4466
Backup Central Contact Email: GSKClinicalSupportHD@gsk.com
Overall Study Official: GSK Clinical Trials
Overall Study Official Affiliation: GlaxoSmithKline
Overall Study Official Role: Study Director
Responsible Party Name/Official Title: Cheri Hudson; Clinical Disclosure Advisor
Responsible Party Organization: GSK Clinical Disclosure
Location and Contact Information: Click to view location information