Back to resultsSafety Study of Olopatadine Nasal Spray
Primary Purpose
Perennial Allergic Rhinitis
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Olopatadine 0.6% nasal spray
Placebo Nasal Spray
Sponsored by
About this trial
This is an interventional treatment trial for Perennial Allergic Rhinitis focused on measuring rhinitis, perennial allergic rhinitis, allergic rhinitis
Eligibility Criteria
Inclusion Criteria:
- Patients with confirmed diagnosis of perennial allergic rhinitis who are 12 years and older
Exclusion Criteria:
- Age 11 years and younger
Sites / Locations
- Waco
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Olopatadine 0.6% Nasal Spray
Placebo Nasal Spray
Arm Description
2 sprays each nostril twice daily
2 sprays each nostril twice daily
Outcomes
Primary Outcome Measures
Mean Response at Day 30 to the Patient-rated Relief Assessment Questionnaire
Mean Patient-Rated Relief Assessment at Day 30. The patient-rated relief assessment (PRRA) was a 4-point scale with 1=Complete Relief; 2=Moderate Relief; 3=Mild Relief; and 4=No Relief.
Secondary Outcome Measures
Average Number of Days of Rescue Medication Taken
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00578331
Brief Title
Safety Study of Olopatadine Nasal Spray
Official Title
Safety Study of Olopatadine Nasal Spray
Study Type
Interventional
2. Study Status
Record Verification Date
February 2010
Overall Recruitment Status
Completed
Study Start Date
December 2006 (undefined)
Primary Completion Date
January 2008 (Actual)
Study Completion Date
January 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alcon Research
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine whether olopatadine nasal spray is safe and effective when used for up to one year by patients with perennial allergic rhinitis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Perennial Allergic Rhinitis
Keywords
rhinitis, perennial allergic rhinitis, allergic rhinitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
890 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Olopatadine 0.6% Nasal Spray
Arm Type
Experimental
Arm Description
2 sprays each nostril twice daily
Arm Title
Placebo Nasal Spray
Arm Type
Placebo Comparator
Arm Description
2 sprays each nostril twice daily
Intervention Type
Drug
Intervention Name(s)
Olopatadine 0.6% nasal spray
Intervention Description
2 sprays each nostril twice daily
Intervention Type
Drug
Intervention Name(s)
Placebo Nasal Spray
Intervention Description
2 sprays each nostril twice daily
Primary Outcome Measure Information:
Title
Mean Response at Day 30 to the Patient-rated Relief Assessment Questionnaire
Description
Mean Patient-Rated Relief Assessment at Day 30. The patient-rated relief assessment (PRRA) was a 4-point scale with 1=Complete Relief; 2=Moderate Relief; 3=Mild Relief; and 4=No Relief.
Time Frame
day 30
Secondary Outcome Measure Information:
Title
Average Number of Days of Rescue Medication Taken
Time Frame
Month 1 through Month 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with confirmed diagnosis of perennial allergic rhinitis who are 12 years and older
Exclusion Criteria:
Age 11 years and younger
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Margaret Drake
Organizational Affiliation
Alcon Research
Official's Role
Study Director
Facility Information:
Facility Name
Waco
City
Waco
State/Province
Texas
ZIP/Postal Code
76712
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Safety Study of Olopatadine Nasal Spray
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