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Efficacy Study for the Symptomatic Treatment of Perennial Allergic Rhinitis With a 1 Year Safety Extension

NCT01127620 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 650

Last updated 2012-09-26

No results posted yet for this study

Summary

Double-blind phase: The objective of the study was to evaluate the efficacy and safety of Bilastine 20 mg, compared to Cetirizine and placebo for the treatment of perennial allergic rhinitis.

Open-label Phase: The objective of this extension was to evaluate the long-term safety of Bilastine 20 mg during one year in the symptomatic treatment of perennial allergic rhinitis

Conditions

  • Perennial Allergic Rhinitis

Interventions

DRUG

Bilastine

20 mg encapsulated tablets

DRUG

Cetirizine

10 mg encapsulated tablets

DRUG

Placebo

encapsulated tablets

Sponsors & Collaborators

  • Faes Farma, S.A.

    lead INDUSTRY

Principal Investigators

  • Piotr Kuna, Prof. MD. · Barlicki University Hospital, Medical University of Lodz (Poland)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-05-31
Primary Completion
2006-03-31
Completion
2006-11-30

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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 NCT01127620 on ClinicalTrials.gov