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NCT00578331 Clinical Trial

Safety Study of Olopatadine Nasal Spray

Perennial Allergic Rhinitis Clinical Trial

Official title:
Safety Study of Olopatadine Nasal Spray

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00578331
Other study ID # C-05-69
Secondary ID
Status Completed
Phase Phase 3
First received December 19, 2007
Last updated September 29, 2017
Start date December 2006
Est. completion date January 2008

Study information
Verified date February 2010
Source Alcon Research
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 890
Est. completion date January 2008
Est. primary completion date January 2008
Accepts healthy volunteers No
Gender All
Age group 12 Years and older
Eligibility Inclusion Criteria:

- Patients with confirmed diagnosis of perennial allergic rhinitis who are 12 years and older

Exclusion Criteria:

- Age 11 years and younger

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Olopatadine 0.6% nasal spray
2 sprays each nostril twice daily
• Placebo Nasal Spray
2 sprays each nostril twice daily

Locations
Country Name City State
United States Waco Waco Texas

Sponsors (1)
Lead Sponsor Collaborator
Alcon Research

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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. day 30
Secondary Average Number of Days of Rescue Medication Taken Month 1 through Month 12
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