Status:
COMPLETED
Safety of PATANASE Nasal Spray in Patients With Perennial Allergic Rhinitis
Lead Sponsor:
Alcon Research
Conditions:
Perennial Allergic Rhinitis
Eligibility:
All Genders
12+ years
Phase:
PHASE4
Brief Summary
The purpose of this study was to assess local nasal adverse effects, as well as systemic effects, of PATANASE nasal spray when compared with Patanase Vehicle, pH 3.7 and Patanase Vehicle, pH 7.0 in pa...
Eligibility Criteria
Inclusion
- Sign informed consent;
- Normal nasal exam;
- History of perennial allergic rhinitis;
- Allergy to perennial allergen documented by allergy testing;
- Age 12 years and older;
- Must follow instructions;
- Must make required study visits;
- Negative pregnancy test and adequate birth control methods for females of childbearing potential;
- Refrain from certain allergy medications during the study;
- Other protocol-defined inclusion criteria may apply.
Exclusion
- Nasal disorders;
- Use of substances that affect the nasal septum;
- Exposure to industrial metal plating solutions;
- Uncontrolled, severe, or unstable diseases;
- Hypersensitivity to the study drug or nasal spray components;
- Relative of site staff with access to the protocol;
- Participation in another investigational study within 30 days or at the same time as this study;
- Medical Monitor decision;
- Other protocol-defined exclusion criteria may apply.
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
1260 Patients enrolled
Trial Details
Trial ID
NCT00789555
Start Date
November 1 2008
End Date
January 1 2011
Last Update
February 8 2018
Active Locations (1)
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1
Contact Alcon Call Center For Trial Locations
Fort Worth, Texas, United States, 76134