Safety and Efficacy of Olopatadine HCl Nasal Spray in 6-11 Year Old Patients
Information source: Alcon Research
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Seasonal Allergic Rhinitis
Intervention: Olopatadine Hydrochloride Nasal Spray 0.6% (Drug); Vehicle (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Alcon Research Official(s) and/or principal investigator(s):
Ed Tumaian, Study Director, Affiliation: ed.tumaian@alconlabs.com
Summary
A study to demonstrate the superiority of test article nasal spray relative to vehicle nasal
spray for the treatment of seasonal allergic rhinitis for a 2 week period in patients aged 6
to 11 years with a history of seasonal allergic rhinitis.
Clinical Details
Official title: Safety and Efficacy of Olopatadine HCl Nasal Spray in 6-11 Year Old Patients
Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Percent Change From Baseline in the Reflective Total Nasal Symptom Score (TNSS)
Secondary outcome: Percent Change From Baseline in the Reflective Total Ocular Symptom Score (TOSS)
Eligibility
Minimum age: 6 Years.
Maximum age: 11 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Male or female; minimum of 6 years of age and less than 12 years
- 2 year history of seasonal allergic rhinitis
Exclusion Criteria:
- Concurrent disease that might interfere with the investigation or evaluation of te
study medication
- Confirmed diagnosis of chronic rhinosinusitis within the last year
- Asthma, with the exception of mild intermittent asthma
- Anatomical nasal deformity
- Nasal obstruction
- Known non-responder to antihistamines for symptoms of Seasonal Allergic Rhinitis
(SAR)
- Chronic or intermittent use of of inhaled, oral, intramuscular intravenous
corticosteroids ot topical steroids
- Ocular disorder other that allergic conjunctivitis
Locations and Contacts
Kenilworth/IL, Kenilworth, Illinois 60043, United States
Additional Information
Starting date: September 2007
Last updated: February 23, 2010
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