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Safety and Pharmacokinetics of Patanase in Pediatric Patients 2 to < 6 Years of Age

This study has been completed.
Sponsor:
Information provided by:
Alcon Research
ClinicalTrials.gov Identifier:
NCT00794144
First received: November 17, 2008
Last updated: February 23, 2010
Last verified: February 2010
Results First Received: January 12, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Basic Science
Condition: Allergic Rhinitis
Interventions: Drug: Olopatadine Hydrochloride Nasal Spray 0.6%
Drug: Olopatadine Hydrochloride Nasal Spray Vehicle

  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 at medical clinics in the U.S. participated from October 03, 2008, through December 03, 2008.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
negative allergic response; enrollment target met

Reporting Groups
  Description
Olopatadine Hydrochloride Nasal Spray 0.6% Olopatadine Hydrochloride Nasal Spray 0.6%
Olopatadine Hydrochloride Nasal Spray Vehicle Olopatadine Hydrochloride Nasal Spray Vehicle

Participant Flow:   Overall Study
    Olopatadine Hydrochloride Nasal Spray 0.6%     Olopatadine Hydrochloride Nasal Spray Vehicle  
STARTED     66     66  
COMPLETED     63     63  
NOT COMPLETED     3     3  



  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
Olopatadine Hydrochloride Nasal Spray 0.6% Olopatadine Hydrochloride Nasal Spray 0.6%
Olopatadine Hydrochloride Nasal Spray Vehicle Olopatadine Hydrochloride Nasal Spray Vehicle
Total Total of all reporting groups

Baseline Measures
    Olopatadine Hydrochloride Nasal Spray 0.6%     Olopatadine Hydrochloride Nasal Spray Vehicle     Total  
Number of Participants  
[units: participants]
  66     66     132  
Age  
[units: participants]
     
<=18 years     66     66     132  
Between 18 and 65 years     0     0     0  
>=65 years     0     0     0  
Gender  
[units: participants]
     
Female     28     36     64  
Male     38     30     68  



  Outcome Measures

1.  Primary:   Number of Participants With Anatomic Nasal Exam Abnormalities   [ Time Frame: Day 1 (Baseline) to Exit ]


  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
No text entered.


  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: Cynthia M. Rusk\Manager, Development, Alcon Research
ClinicalTrials.gov Identifier: NCT00794144     History of Changes
Other Study ID Numbers: C-07-02
Study First Received: November 17, 2008
Results First Received: January 12, 2010
Last Updated: February 23, 2010
Health Authority: United States: Food and Drug Administration