drugset / Trial / NCT00574379
Efficacy, Safety and PK of Once or Twice Daily Bilastine (10 or 20 mg) Compared With Placebo in the Symptomatic Treatment of SAR
Phase 2
Completed
805 enrolled
Faes Farma, S.A.
Allied Research International · collabMerck Sharp & Dohme LLC · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
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.
Timeline
- Start
- 2007-12
- Primary completion
- 2008-03
- Completion
- 2008-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bilastine | Small molecule | 10 mg | Oral |
| Subject | Bilastine | Small molecule | 20 mg | Oral |