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

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

805 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-12-31

Study Completion Date

2008-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Seasonal Allergic Rhinitis Hay Fever Allergic Conjunctivitis Hypersensitivity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Bilastine 20mg once per day

Group Type EXPERIMENTAL

Bilastine

Intervention Type DRUG

Bilastine 10 or 20mg, once or twice daily for 14 days. Tablets

2

Bilastine 20mg twice per day

Group Type EXPERIMENTAL

Bilastine

Intervention Type DRUG

Bilastine 10 or 20mg, once or twice daily for 14 days. Tablets

3

Bilastine 10mg once per day

Group Type EXPERIMENTAL

Bilastine

Intervention Type DRUG

Bilastine 10 or 20mg, once or twice daily for 14 days. Tablets

4

Bilastine 10mg twice per day

Group Type EXPERIMENTAL

Bilastine

Intervention Type DRUG

Bilastine 10 or 20mg, once or twice daily for 14 days. Tablets

5

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Intervention Type DRUG

Placebo

Placebo tablets twice daily for 14 days

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role collaborator

Allied Research International

INDUSTRY

Sponsor Role collaborator

Faes Farma, S.A.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

MetaClin Research Inc.

Austin, Texas, United States

Site Status

Austin Clinical Research

Austin, Texas, United States

Site Status

Lovelace Scientific Resources

Austin, Texas, United States

Site Status

Kerrville Research Associates

Kerrville, Texas, United States

Site Status

Biogenics Research Institute

San Antonio, Texas, United States

Site Status

DGD Research

San Antonio, Texas, United States

Site Status

Diagnostics Research Group

San Antonio, Texas, United States

Site Status

Southwest Allergy and Asthma Centre

San Antonio, Texas, United States

Site Status

Sylvana Research Associates

San Antonio, Texas, United States

Site Status

Live Oak Allergy and Asthma

San Antonio, Texas, United States

Site Status

Allergy & Asthma Care of Waco

Waco, Texas, United States

Site Status

Allergy Asthma Research Institute

Waco, Texas, United States

Site Status

Countries

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United States

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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