search
Back to results

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

Primary Purpose

Seasonal Allergic Rhinitis, Hay Fever, Allergic Conjunctivitis

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Bilastine
Placebo
Sponsored by
Faes Farma, S.A.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Seasonal Allergic Rhinitis focused on measuring Allergic Rhinitis, Mountain Cedar Pollen, Pollen Allergy, Rhinoconjunctivitis

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Oklahoma Allergy and Asthma Clinic
  • MetaClin Research Inc.
  • Austin Clinical Research
  • Lovelace Scientific Resources
  • Kerrville Research Associates
  • Biogenics Research Institute
  • DGD Research
  • Diagnostics Research Group
  • Southwest Allergy and Asthma Centre
  • Sylvana Research Associates
  • Live Oak Allergy and Asthma
  • Allergy & Asthma Care of Waco
  • Allergy Asthma Research Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

1

2

3

4

5

Arm Description

Bilastine 20mg once per day

Bilastine 20mg twice per day

Bilastine 10mg once per day

Bilastine 10mg twice per day

Outcomes

Primary Outcome Measures

Change in nasal symptom scores

Secondary Outcome Measures

Change in ocular symptom scores and quality of life scores; standard safety assessments

Full Information

First Posted
December 14, 2007
Last Updated
February 13, 2019
Sponsor
Faes Farma, S.A.
Collaborators
Merck Sharp & Dohme LLC, Allied Research International
search

1. Study Identification

Unique Protocol Identification Number
NCT00574379
Brief Title
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

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
December 2007 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
March 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Faes Farma, S.A.
Collaborators
Merck Sharp & Dohme LLC, Allied Research International

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Seasonal Allergic Rhinitis, Hay Fever, Allergic Conjunctivitis, Hypersensitivity
Keywords
Allergic Rhinitis, Mountain Cedar Pollen, Pollen Allergy, Rhinoconjunctivitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
805 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Bilastine 20mg once per day
Arm Title
2
Arm Type
Experimental
Arm Description
Bilastine 20mg twice per day
Arm Title
3
Arm Type
Experimental
Arm Description
Bilastine 10mg once per day
Arm Title
4
Arm Type
Experimental
Arm Description
Bilastine 10mg twice per day
Arm Title
5
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Bilastine
Intervention Description
Bilastine 10 or 20mg, once or twice daily for 14 days. Tablets
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo tablets twice daily for 14 days
Primary Outcome Measure Information:
Title
Change in nasal symptom scores
Time Frame
14 days
Secondary Outcome Measure Information:
Title
Change in ocular symptom scores and quality of life scores; standard safety assessments
Time Frame
14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ander Sologuren, MD
Organizational Affiliation
Faes Farma, S.A.
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Paul Ratner, MD
Organizational Affiliation
Sylvana Research Associates
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oklahoma Allergy and Asthma Clinic
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
MetaClin Research Inc.
City
Austin
State/Province
Texas
ZIP/Postal Code
78704
Country
United States
Facility Name
Austin Clinical Research
City
Austin
State/Province
Texas
ZIP/Postal Code
78750
Country
United States
Facility Name
Lovelace Scientific Resources
City
Austin
State/Province
Texas
ZIP/Postal Code
78759
Country
United States
Facility Name
Kerrville Research Associates
City
Kerrville
State/Province
Texas
ZIP/Postal Code
78028-6071
Country
United States
Facility Name
Biogenics Research Institute
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
DGD Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Diagnostics Research Group
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Southwest Allergy and Asthma Centre
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Sylvana Research Associates
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Live Oak Allergy and Asthma
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78233
Country
United States
Facility Name
Allergy & Asthma Care of Waco
City
Waco
State/Province
Texas
ZIP/Postal Code
76708
Country
United States
Facility Name
Allergy Asthma Research Institute
City
Waco
State/Province
Texas
ZIP/Postal Code
76712
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs