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Safety Study of Olopatadine Nasal Spray

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00578331
First Posted: December 21, 2007
Last Update Posted: October 31, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Alcon Research
December 19, 2007
December 21, 2007
July 7, 2009
February 3, 2010
October 31, 2017
December 2006
January 2008   (Final data collection date for primary outcome measure)
Mean Response at Day 30 to the Patient-rated Relief Assessment Questionnaire [ Time Frame: day 30 ]
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.
Mean Response at Day 30 to the Patient-rated Relief Assessment Questionnaire [ Time Frame: day 30 ]
Complete list of historical versions of study NCT00578331 on ClinicalTrials.gov Archive Site
Average Number of Days of Rescue Medication Taken [ Time Frame: Month 1 through Month 12 ]
average number of days to rescue mediciation was used and the mean response (average of visits 2 through the last scheduled or unscheduled visit) to the patient-rated relief assessment questionnaire. [ Time Frame: from baseline ]
Not Provided
Not Provided
 
Safety Study of Olopatadine Nasal Spray
Safety Study of Olopatadine Nasal Spray
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Perennial Allergic Rhinitis
  • Drug: Olopatadine 0.6% nasal spray
    2 sprays each nostril twice daily
  • Drug: Placebo Nasal Spray
    2 sprays each nostril twice daily
  • Experimental: Olopatadine 0.6% Nasal Spray
    2 sprays each nostril twice daily
    Intervention: Drug: Olopatadine 0.6% nasal spray
  • Placebo Comparator: Placebo Nasal Spray
    2 sprays each nostril twice daily
    Intervention: Drug: Placebo Nasal Spray
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
890
January 2008
January 2008   (Final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • Age 11 years and younger
Sexes Eligible for Study: All
12 Years and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00578331
C-05-69
No
Not Provided
Not Provided
Alcon Research
Alcon Research
Not Provided
Study Director: Margaret Drake Alcon Research
Alcon Research
February 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP