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
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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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

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 ]

2.  Secondary:   Average Number of Days of Rescue Medication Taken   [ Time Frame: Month 1 through Month 12 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Alcon Clinical
Organization: Alcon Research, Ltd.
phone: 888.451.3937; 817.568.6725
e-mail: medinfo@alconlabs.com


No publications provided


Responsible Party: Margaret Drake, Alcon
ClinicalTrials.gov Identifier: NCT00578331     History of Changes
Other Study ID Numbers: C-05-69
Study First Received: December 19, 2007
Results First Received: July 7, 2009
Last Updated: February 23, 2010
Health Authority: United States: Food and Drug Administration