Safety Study of Olopatadine Nasal Spray
1 other identifier
interventional
890
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Dec 2006
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2006
CompletedFirst Submitted
Initial submission to the registry
December 19, 2007
CompletedFirst Posted
Study publicly available on registry
December 21, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2008
CompletedResults Posted
Study results publicly available
February 3, 2010
CompletedOctober 31, 2017
February 1, 2010
1.1 years
December 19, 2007
July 7, 2009
September 29, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mean Response at Day 30 to the Patient-rated Relief Assessment Questionnaire
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.
day 30
Secondary Outcomes (1)
Average Number of Days of Rescue Medication Taken
Month 1 through Month 12
Study Arms (2)
Olopatadine 0.6% Nasal Spray
EXPERIMENTAL2 sprays each nostril twice daily
Placebo Nasal Spray
PLACEBO COMPARATOR2 sprays each nostril twice daily
Interventions
Eligibility Criteria
You may qualify if:
- Patients with confirmed diagnosis of perennial allergic rhinitis who are 12 years and older
You may not qualify if:
- Age 11 years and younger
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Alcon Researchlead
Study Sites (1)
Waco
Waco, Texas, 76712, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Alcon Clinical
- Organization
- Alcon Research, Ltd.
Study Officials
- STUDY DIRECTOR
Margaret Drake
Alcon Research
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 19, 2007
First Posted
December 21, 2007
Study Start
December 1, 2006
Primary Completion
January 1, 2008
Study Completion
January 1, 2008
Last Updated
October 31, 2017
Results First Posted
February 3, 2010
Record last verified: 2010-02