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Efficacy Study for the Symptomatic Treatment of Chronic Idiopathic Urticaria

NCT00421109 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 522

Last updated 2012-04-05

No results posted yet for this study

Summary

The objective of the study is to evaluate the efficacy and tolerability of Bilastine 20 mg Q.D., compared to Levocetirizine 5 mg Q.D. and placebo for the treatment of Chronic Idiopathic Urticaria.

Conditions

  • Urticaria

Interventions

DRUG

Bilastine

Encapsulated 20 mg Tablet. Once daily for 28 days

DRUG

Levocetirizine

Encapsulated 5 mg tablet. Once daily for 28 days

DRUG

Placebo

Encapsulated tablet. Once daily for 28 days

Sponsors & Collaborators

  • Faes Farma, S.A.

    lead INDUSTRY

Principal Investigators

  • OLMOS, MD · HOSP CLINICO SAN CARLOS, SERVICIO DERMATOLOGIA (Madrid- Spain)

  • DE WEERT, MD · UZ GENT/ DE PINTELAAN 185 (Belgium)

  • DUBERTRET, MD · HOPITAL ST LOUIS/SCE DERMATOLOGIE/1 AV. CLAUDE VELLEFAUX (Paris- France)

  • SIMON, MD · UNIV. KLINIKUM LEIPZIG/KLINIK FÜR DERMATOLOGIE (Germany)

  • KAPINSKA-MROWIECKA, MD · SZPITAL SPECJALISTYCZNY IM.S. ZEROMSKIEGO/ODDZIAL DERMATOLOGII/ OS. MLODOSCI 11 (Krakow- Poland)

  • BENEA, MD · Spit Clin Dermato-Venero."Prof.Dr./Scarlat Longhin"/Calea Serban Voda216,sector4 (Bucharest- Romania)

  • HERRERO, MD · CONSULTORIO DE ALERGIA 1° PISO/HOSPITAL JUAN A. FERNANDEZ/CERVINO 3355 (Buenos Aires- Argentina)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2006-07-31
Primary Completion
2007-07-31
Completion
2007-07-31

Countries

  • Argentina
  • Belgium
  • France
  • Germany
  • Poland
  • Romania
  • Spain

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 NCT00421109 on ClinicalTrials.gov