Phase 3
Completed N=2,388
Safety and Efficacy of Olopatadine HCl Nasal Spray in 6-11 Year Old Patients
Source: ClinicalTrials.gov NCT00578929 ↗Enrolled (actual)
2,388
Serious AEs
0.0%
Results posted
Feb 2010
Primary outcomePrimary: Percent Change From Baseline in the Reflective Total Nasal Symptom Score (TNSS) — -25.10; -18.17; -26.35; -21.21 Percent change of TNSS from baseline
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline in the Reflective Total Nasal Symptom Score (TNSS) |
-25.10; -18.17; -26.35; -21.21 | — |
| SECONDARY Percent Change From Baseline in the Reflective Total Ocular Symptom Score (TOSS) |
-25.02; -6.09; -25.03; -9.46 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00578929). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.