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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.
Details
| Lead sponsor | Faes Farma, S.A. |
|---|---|
| Phase | Phase 2 |
| Status | COMPLETED |
| Enrolment | 805 |
| Start date | 2007-12 |
| Completion | 2008-03 |
Conditions
- Seasonal Allergic Rhinitis
- Hay Fever
- Allergic Conjunctivitis
- Hypersensitivity
Interventions
- Bilastine
- Placebo
Primary outcomes
- Change in nasal symptom scores — 14 days
Countries
United States