Clinical trial NCT00574379: Efficacy, Safety and PK of Once or Twice Daily Bilastine (10 or 20 mg) Compared With Placebo in the Symptomatic Treatment of SAR
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Seasonal Allergic Rhinitis
Hay Fever
Allergic Conjunctivitis
Hypersensitivity
Keywords: Allergic Rhinitis
Mountain Cedar Pollen
Pollen Allergy
Rhinoconjunctivitis
Lead sponsor: Faes Farma, S.A.
Sponsor class: INDUSTRY
Collaborators: name: Merck Sharp & Dohme LLC
name: Allied Research International
First posted: 2007-12-17
Enrollment: 805
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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

Primary outcomes:
measure: Change in nasal symptom scores
timeFrame: 14 days
Secondary outcomes:
measure: Change in ocular symptom scores and quality of life scores; standard safety assessments
timeFrame: 14 days
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: Oklahoma Allergy and Asthma Clinic
state: Oklahoma
city: Austin
country: United States
facility: MetaClin Research Inc.
state: Texas
city: Austin
country: United States
facility: Austin Clinical Research
state: Texas
city: Austin
country: United States
facility: Lovelace Scientific Resources
state: Texas
city: Kerrville
country: United States
facility: Kerrville Research Associates
state: Texas
city: San Antonio
country: United States
facility: Biogenics Research Institute
state: Texas
city: San Antonio
country: United States
facility: DGD Research
state: Texas
city: San Antonio
country: United States
facility: Diagnostics Research Group
state: Texas
city: San Antonio
country: United States
facility: Southwest Allergy and Asthma Centre
state: Texas
city: San Antonio
country: United States
facility: Sylvana Research Associates
state: Texas
city: San Antonio
country: United States
facility: Live Oak Allergy and Asthma
state: Texas
city: Waco
country: United States
facility: Allergy & Asthma Care of Waco
state: Texas
city: Waco
country: United States
facility: Allergy Asthma Research Institute
state: Texas
Study officials:
affiliation: Faes Farma, S.A.
name: Ander Sologuren, MD
role: STUDY_DIRECTOR
affiliation: Sylvana Research Associates
name: Paul Ratner, MD
role: PRINCIPAL_INVESTIGATOR
References: