Safety of PATANASE Nasal Spray in Patients With Perennial Allergic Rhinitis
NCT ID: NCT00789555
Last Updated: 2018-02-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
1260 participants
INTERVENTIONAL
2008-11-30
2011-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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PATANASE
Olopatadine hydrochloride 0.6% nasal spray (PATANASE), two sprays in each nostril twice a day (morning and evening) for up to 12 months
Olopatadine hydrochloride 0.6% nasal spray (PATANASE)
Two sprays in each nostril twice a day (morning and evening) for up to 12 months
Patanase Vehicle, pH 3.7
Olopatadine nasal spray vehicle, pH 3.7, two sprays in each nostril twice a day (morning and evening) for up to 12 months
Olopatadine nasal spray vehicle, pH 3.7
Two sprays in each nostril twice a day (morning and evening) for up to 12 months
Patanase Vehicle, pH 7.0
Olopatadine nasal spray vehicle, pH 7.0, two sprays in each nostril twice a day (morning and evening) for up to 12 months
Olopatadine nasal spray vehicle, pH 7.0
Two sprays in each nostril twice a day (morning and evening) for up to 12 months
Interventions
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Olopatadine hydrochloride 0.6% nasal spray (PATANASE)
Two sprays in each nostril twice a day (morning and evening) for up to 12 months
Olopatadine nasal spray vehicle, pH 3.7
Two sprays in each nostril twice a day (morning and evening) for up to 12 months
Olopatadine nasal spray vehicle, pH 7.0
Two sprays in each nostril twice a day (morning and evening) for up to 12 months
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Normal nasal exam;
3. History of perennial allergic rhinitis;
4. Allergy to perennial allergen documented by allergy testing;
5. Age 12 years and older;
6. Must follow instructions;
7. Must make required study visits;
8. Negative pregnancy test and adequate birth control methods for females of childbearing potential;
9. Refrain from certain allergy medications during the study;
Exclusion Criteria
2. Use of substances that affect the nasal septum;
3. Exposure to industrial metal plating solutions;
4. Uncontrolled, severe, or unstable diseases;
5. Hypersensitivity to the study drug or nasal spray components;
6. Relative of site staff with access to the protocol;
7. Participation in another investigational study within 30 days or at the same time as this study;
8. Medical Monitor decision;
12 Years
ALL
No
Sponsors
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Alcon Research
INDUSTRY
Responsible Party
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Locations
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Contact Alcon Call Center For Trial Locations
Fort Worth, Texas, United States
Countries
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Other Identifiers
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C-08-32
Identifier Type: -
Identifier Source: org_study_id
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