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

This study has been completed.
Sponsor:
Collaborators:
Merck Sharp & Dohme Corp.
Allied Research International
Information provided by:
Faes Farma, S.A.
ClinicalTrials.gov Identifier:
NCT00574379
First received: December 14, 2007
Last updated: January 9, 2009
Last verified: January 2009
  Purpose
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.

Condition Intervention Phase
Seasonal Allergic Rhinitis Hay Fever Allergic Conjunctivitis Hypersensitivity Drug: Bilastine Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Further study details as provided by Faes Farma, S.A.:

Primary Outcome Measures:
  • Change in nasal symptom scores [ Time Frame: 14 days ]

Secondary Outcome Measures:
  • Change in ocular symptom scores and quality of life scores; standard safety assessments [ Time Frame: 14 days ]

Enrollment: 805
Study Start Date: December 2007
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Bilastine 20mg once per day
Drug: Bilastine
Bilastine 10 or 20mg, once or twice daily for 14 days. Tablets
Experimental: 2
Bilastine 20mg twice per day
Drug: Bilastine
Bilastine 10 or 20mg, once or twice daily for 14 days. Tablets
Experimental: 3
Bilastine 10mg once per day
Drug: Bilastine
Bilastine 10 or 20mg, once or twice daily for 14 days. Tablets
Experimental: 4
Bilastine 10mg twice per day
Drug: Bilastine
Bilastine 10 or 20mg, once or twice daily for 14 days. Tablets
Placebo Comparator: 5 Drug: Placebo
Placebo tablets twice daily for 14 days

  Eligibility

Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00574379

Locations
United States, Oklahoma
Oklahoma Allergy and Asthma Clinic
Oklahoma City, Oklahoma, United States, 73104
United States, Texas
MetaClin Research Inc.
Austin, Texas, United States, 78704
Austin Clinical Research
Austin, Texas, United States, 78750
Lovelace Scientific Resources
Austin, Texas, United States, 78759
Kerrville Research Associates
Kerrville, Texas, United States, 78028-6071
Biogenics Research Institute
San Antonio, Texas, United States, 78229
DGD Research
San Antonio, Texas, United States, 78229
Diagnostics Research Group
San Antonio, Texas, United States, 78229
Southwest Allergy and Asthma Centre
San Antonio, Texas, United States, 78229
Sylvana Research Associates
San Antonio, Texas, United States, 78229
Live Oak Allergy and Asthma
San Antonio, Texas, United States, 78233
Allergy & Asthma Care of Waco
Waco, Texas, United States, 76708
Allergy Asthma Research Institute
Waco, Texas, United States, 76712
Sponsors and Collaborators
Faes Farma, S.A.
Merck Sharp & Dohme Corp.
Allied Research International
Investigators
Study Director: Ander Sologuren, MD Faes Farma, S.A.
Principal Investigator: Paul Ratner, MD Sylvana Research Associates
  More Information

Responsible Party: Ander Sologuren, MD, Faes Farma, S.A.
ClinicalTrials.gov Identifier: NCT00574379     History of Changes
Other Study ID Numbers: BILA 2607/RAE
CTFZ07001
Study First Received: December 14, 2007
Last Updated: January 9, 2009

Keywords provided by Faes Farma, S.A.:
Allergic Rhinitis
Mountain Cedar Pollen
Pollen Allergy
Rhinoconjunctivitis

Additional relevant MeSH terms:
Rhinitis
Rhinitis, Allergic
Hypersensitivity
Conjunctivitis
Rhinitis, Allergic, Seasonal
Conjunctivitis, Allergic
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Conjunctival Diseases
Eye Diseases

ClinicalTrials.gov processed this record on September 21, 2017