Efficacy, Safety and PK of Once or Twice Daily Bilastine (10 or 20 mg) Compared With Placebo in the Symptomatic Treatment of SAR
| Status: | Completed |
|---|---|
| Conditions: | Allergy, Neurology, Ocular |
| Therapuetic Areas: | Neurology, Ophthalmology, Otolaryngology |
| Healthy: | No |
| Age Range: | 12 - Any |
| Updated: | 2/17/2019 |
| Start Date: | December 2007 |
| End Date: | March 2008 |
A Multi-Center Randomized, Double-Blind, Placebo-Controlled, Parallel Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Once or Twice Daily Bilastine (10 or 20 mg) Compared With Placebo Given Orally in The Treatment of the Symptoms of Seasonal Allergic Rhino-Conjunctivitis With Allergy to Mountain Cedar Pollen
Evaluate the relative efficacy of four dosing regimens of bilastine tablets (given either
once or twice per day) versus placebo in patients with Seasonal Allergic Rhinitis (SAR) in
the Mountain Cedar season in south Texas and Oklahoma based on the mean change from baseline
in Reflective Total Nasal Symptom Scores (TNSS) assessed over 14 days of treatment.
once or twice per day) versus placebo in patients with Seasonal Allergic Rhinitis (SAR) in
the Mountain Cedar season in south Texas and Oklahoma based on the mean change from baseline
in Reflective Total Nasal Symptom Scores (TNSS) assessed over 14 days of treatment.
Inclusion Criteria:
- clinical history of Seasonal Allergic Rhinoconjunctivitis with seasonal onset and
offset of nasal allergy symptoms
- documentation of a positive skin test within one year of screening to Mountain Cedar
allergen
Exclusion Criteria:
- significant medical condition
- significant nasal abnormality
- significant cardiac condition
- recent infection
- use of other allergy medication during the study
We found this trial at
13
sites
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