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PK/PD and Steady State Efficacy Study of Bilastine Compared With Placebo Given Orally in the Treatment of the Symptoms of SAR in an EEC Model (5-arm)

NCT00574210 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 502

Last updated 2019-02-15

No results posted yet for this study

Summary

The purpose of this study is to evaluate the relative efficacy of four dosing regimens of bilastine tablets versus placebo in subjects with SAR exposed in controlled ragweed pollen using the EEC model based on the mean change from baseline in Total Nasal Symptom Scores (TNSS). Study includes male and female subjects, aged 18 and 65 years with clinical history of SAR with seasonal onset and offset of nasal allergy symptoms during each of the last two ragweed allergy seasons and a positive skin prick test to ragweed allergen within 12 months prior to randomization.

Conditions

  • Seasonal Allergic Rhinitis
  • Hay Fever
  • Rhinoconjunctivitis

Interventions

DRUG

Bilastine

Bilastine Tablets, administered at a dosage strength of 10 mg or 20 mg, once or twice per day.

DRUG

Placebo

Placebo Tablets administered twice per day

Sponsors & Collaborators

  • Allied Research International

    collaborator INDUSTRY

  • Faes Farma, S.A.

    lead INDUSTRY

Principal Investigators

  • Roman Valiente, MD · Faes Farma, S.A.

  • Piyush Patel, MD · Allied Research International Inc

  • Deepen Patel, MD, CCFP · Allied Research International Inc

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-10-31
Primary Completion
2008-02-29
Completion
2008-02-29

Countries

  • Canada

Study Locations

More Related Trials

Entities

Drugs

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 NCT00574210 on ClinicalTrials.gov