Efficacy, Safety and PK of Once or Twice Daily Bilastine (10 or 20 mg) Compared With Placebo in the Symptomatic Treatment of SAR
NCT ID: NCT00574379
Last Updated: 2019-02-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
805 participants
INTERVENTIONAL
2007-12-31
2008-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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1
Bilastine 20mg once per day
Bilastine
Bilastine 10 or 20mg, once or twice daily for 14 days. Tablets
2
Bilastine 20mg twice per day
Bilastine
Bilastine 10 or 20mg, once or twice daily for 14 days. Tablets
3
Bilastine 10mg once per day
Bilastine
Bilastine 10 or 20mg, once or twice daily for 14 days. Tablets
4
Bilastine 10mg twice per day
Bilastine
Bilastine 10 or 20mg, once or twice daily for 14 days. Tablets
5
Placebo
Placebo tablets twice daily for 14 days
Interventions
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Bilastine
Bilastine 10 or 20mg, once or twice daily for 14 days. Tablets
Placebo
Placebo tablets twice daily for 14 days
Eligibility Criteria
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Inclusion Criteria
* documentation of a positive skin test within one year of screening to Mountain Cedar allergen
Exclusion Criteria
* significant nasal abnormality
* significant cardiac condition
* recent infection
* use of other allergy medication during the study
12 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Allied Research International
INDUSTRY
Faes Farma, S.A.
INDUSTRY
Responsible Party
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Principal Investigators
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Ander Sologuren, MD
Role: STUDY_DIRECTOR
Faes Farma, S.A.
Paul Ratner, MD
Role: PRINCIPAL_INVESTIGATOR
Sylvana Research Associates
Locations
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Oklahoma Allergy and Asthma Clinic
Oklahoma City, Oklahoma, United States
MetaClin Research Inc.
Austin, Texas, United States
Austin Clinical Research
Austin, Texas, United States
Lovelace Scientific Resources
Austin, Texas, United States
Kerrville Research Associates
Kerrville, Texas, 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
Southwest Allergy and Asthma Centre
San Antonio, Texas, United States
Sylvana Research Associates
San Antonio, Texas, United States
Live Oak Allergy and Asthma
San Antonio, Texas, United States
Allergy & Asthma Care of Waco
Waco, Texas, United States
Allergy Asthma Research Institute
Waco, Texas, United States
Countries
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Other Identifiers
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CTFZ07001
Identifier Type: -
Identifier Source: secondary_id
BILA 2607/RAE
Identifier Type: -
Identifier Source: org_study_id
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