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Safety and Efficacy of AL-53817 Nasal Spray Solution

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01454505
First received: October 17, 2011
Last updated: March 29, 2013
Last verified: March 2013
History of Changes
Results First Received: March 29, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Conditions: Nasal Allergies
Allergies
Interventions: Drug: AL-53817 nasal spray solution
Other: Vehicle 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
Subjects were recruited from one study center in Canada.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
50 healthy volunteers were enrolled in Stage A and subsequently exited from the study. 60 unique patients were enrolled in Stage B.

Reporting Groups
  Description
Stage A/AL-53817 AL-53817 nasal spray solution in 1 of 3 concentrations, 1 or 2 sprays per nostril, single dose
Stage A/Vehicle Vehicle, 1 or 2 sprays per nostril, single dose
Stage B/AL-53817 AL-53817 nasal spray solution, 1 spray per nostril twice a day for 4 days. On Day 5, 1 spray per nostril 60 minutes before entering the EEC.
Stage B/Vehicle Vehicle nasal spray, 1 spray per nostril twice a day for 4 days. On Day 5, 1 spray per nostril 60 minutes before entering the EEC.

Participant Flow:   Overall Study
    Stage A/AL-53817     Stage A/Vehicle     Stage B/AL-53817     Stage B/Vehicle  
STARTED     35     15     40     20  
COMPLETED     35     15     40     20  
NOT COMPLETED     0     0     0     0  



  Baseline Characteristics
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Reporting Groups
  Description
Stage A/Healthy Volunteers AL-53817 nasal spray solution in 1 of 3 concentration doses, 1 or 2 sprays per nostril, OR Vehicle, 1 spray per nostril
Stage B/AL-53817 AL-53817 nasal spray solution, 1 spray per nostril twice a day for 4 days. On Day 5, 1 spray per nostril 60 minutes before entering the EEC.
Stage B/Vehicle Vehicle nasal spray, 1 spray per nostril twice a day for 4 days. On Day 5, 1 spray per nostril 60 minutes before entering the EEC.
Total Total of all reporting groups

Baseline Measures
    Stage A/Healthy Volunteers     Stage B/AL-53817     Stage B/Vehicle     Total  
Number of Participants  
[units: participants]
 		  50     40     20     110  
Age, Customized  
[units: participants]
 		       
<65     49     39     20     108  
≥65     1     1     0     2  
Gender  
[units: participants]
 		       
Female     25     23     15     63  
Male     25     17     5     47  
Region of Enrollment  
[units: participants]
 		       
Canada     50     40     20     110  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Adverse Events in Stage A   [ Time Frame: Day 1 ]
  Show Outcome Measure 1

2.  Primary:   Mean Change From Baseline in Nasal Congestion Over a 6-hour Period in the EEC at Day 5   [ Time Frame: Baseline (pretreatment), Day 5 ]
  Show Outcome Measure 2

3.  Secondary:   Mean Change From Baseline in Total Nasal Symptom Scores (TNSS) Over a 6-hour Period in the EEC at Day 5   [ Time Frame: Baseline (pretreatment), Day 5 ]
  Show Outcome Measure 3


  Serious Adverse Events
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  Other Adverse Events
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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.


Limitations and Caveats
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.  


Results Point of Contact:  
Name/Title: Terri Pasquine, Clinical Project Lead
Organization: Alcon Research, Ltd.
phone: 1-888-451-3937
e-mail: alcon.medinfo@alcon.com


No publications provided


Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01454505     History of Changes
Other Study ID Numbers: C-10-094
Study First Received: October 17, 2011
Results First Received: March 29, 2013
Last Updated: March 29, 2013
Health Authority: Canada: Health Canada