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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

NCT00574379 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 805

Last updated 2019-02-15

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Bilastine

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

DRUG

Placebo

Placebo tablets twice daily for 14 days

Sponsors & Collaborators

  • Merck Sharp & Dohme LLC

    collaborator INDUSTRY

  • Allied Research International

    collaborator INDUSTRY

  • Faes Farma, S.A.

    lead INDUSTRY

Principal Investigators

  • Ander Sologuren, MD · Faes Farma, S.A.

  • Paul Ratner, MD · Sylvana Research Associates

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-12-31
Primary Completion
2008-03-31
Completion
2008-03-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00574379 on ClinicalTrials.gov