NCT00574379

Efficacy, Safety and PK of Once or Twice Daily Bilastine (10 or 20 mg) Compared With Placebo in the Symptomatic Treatment of SAR

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 805 (actual)
• Sponsor: Faes Farma, S.A. · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Seasonal Allergic Rhinitis
• Hay Fever
• Allergic Conjunctivitis
• Hypersensitivity

Interventions

Type	Name	Description
DRUG	Bilastine	Bilastine 10 or 20mg, once or twice daily for 14 days. Tablets
DRUG	Placebo	Placebo tablets twice daily for 14 days

Timeline

• Start date: 2007-12-01
• Primary completion: 2008-03-01
• Completion: 2008-03-01
• First posted: 2007-12-17
• Last updated: 2019-02-15

Locations

13 sites across 1 country: United States