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
• Trial end date: 2008-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Faes Farma, S.A.
• Collaborators: Allied Research International; Merck Sharp & Dohme Corp.

Criteria

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