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NCT00574379 Clinical Trial

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

Seasonal Allergic Rhinitis Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00574379
Other study ID # BILA 2607/RAE
Secondary ID CTFZ07001
Status Completed
Phase Phase 2
First received
Last updated
Start date December 2007
Est. completion date March 2008

Study information
Verified date February 2019
Source Faes Farma, S.A.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 805
Est. completion date March 2008
Est. primary completion date March 2008
Accepts healthy volunteers No
Gender All
Age group 12 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Bilastine
Bilastine 10 or 20mg, once or twice daily for 14 days. Tablets
• Placebo
Placebo tablets twice daily for 14 days

Locations
Country Name City State
United States Austin Clinical Research Austin Texas
United States Lovelace Scientific Resources Austin Texas
United States MetaClin Research Inc. Austin Texas
United States Kerrville Research Associates Kerrville Texas
United States Oklahoma Allergy and Asthma Clinic Oklahoma City Oklahoma
United States Biogenics Research Institute San Antonio Texas
United States DGD Research San Antonio Texas
United States Diagnostics Research Group San Antonio Texas
United States Live Oak Allergy and Asthma San Antonio Texas
United States Southwest Allergy and Asthma Centre San Antonio Texas
United States Sylvana Research Associates San Antonio Texas
United States Allergy & Asthma Care of Waco Waco Texas
United States Allergy Asthma Research Institute Waco Texas

Sponsors (3)
Lead Sponsor Collaborator
Faes Farma, S.A. Allied Research International, Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in nasal symptom scores 14 days
Secondary Change in ocular symptom scores and quality of life scores; standard safety assessments 14 days
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