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Safety Study of Olopatadine Nasal Spray

This study has been completed.
Sponsor:
Information provided by:
Alcon Research
ClinicalTrials.gov Identifier:
NCT00578331
First received: December 19, 2007
Last updated: February 23, 2010
Last verified: February 2010
History of Changes
Results First Received: July 7, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Perennial Allergic Rhinitis
Interventions: Drug: Olopatadine 0.6% nasal spray
Drug: Placebo Nasal Spray

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients were recruited between December 2006 and January 2007 at medical offices in the United States.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients were randomized at Visit 1 upon meeting inclusion/exclusion.

Reporting Groups
  Description
Placebo Nasal Spray 2 sprays each nostril twice daily
Olopatadine 0.6% Nasal Spray 2 sprays each nostril twice daily

Participant Flow:   Overall Study
    Placebo Nasal Spray     Olopatadine 0.6% Nasal Spray  
STARTED     445     445  
COMPLETED     329     320  
NOT COMPLETED     116     125  



  Baseline Characteristics
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Reporting Groups
  Description
Placebo Nasal Spray No text entered.
Olopatadine 0.6% Nasal Spray No text entered.
Total Total of all reporting groups

Baseline Measures
    Placebo Nasal Spray     Olopatadine 0.6% Nasal Spray     Total  
Number of Participants  
[units: participants]
 		  445     445     890  
Age  
[units: participants]
 		     
<=18 years     53     46     99  
Between 18 and 65 years     383     388     771  
>=65 years     9     11     20  
Gender  
[units: participants]
 		     
Female     296     282     578  
Male     149     163     312  



  Outcome Measures
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1.  Primary:   Mean Response at Day 30 to the Patient-rated Relief Assessment Questionnaire   [ Time Frame: day 30 ]
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2.  Secondary:   Average Number of Days of Rescue Medication Taken   [ Time Frame: Month 1 through Month 12 ]
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  Serious Adverse Events
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  Other Adverse Events
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  More Information
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