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Pharmacokinetic Study of Bilastine in Children From 2 to < 12 Years of Age With Either Allergic Rhinoconjunctivitis (AR) or Chronic Urticaria (CU)

NCT01081574 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2012-09-26

No results posted yet for this study

Summary

The conduct of this clinical trial is aimed at determining the most suitable dose regimen for children in different age groups, and secondarily to assess the safety and tolerability of bilastine in this paediatric population subset.

Conditions

  • Allergic Rhinoconjunctivitis
  • Chronic Urticaria

Interventions

DRUG

Bilastine

10 mg/qd/ 7 days.Oral dispersible tablets

Sponsors & Collaborators

  • Faes Farma, S.A.

    lead INDUSTRY

Principal Investigators

  • Ulrich Wahn, Prof. Dr. · International Coordinating Investigator. Charité - Universitätsmedizin Berlin (Germany)

  • Regina Föster-Holst, Prof. Dr. · Universitäts-Hautklinik Kiel (Germany)

  • Belén Sádaba, Dr. · Clínica Universitaria de Navarra (Spain)

  • Gunilla Hedlin, Prof. Dr. · Karolinska University Hospital

  • Stefan Zielen, Prof. Dr. · J.W. Goethe-Universität Frankfurt (Germany)

  • Lennart Nordvall, Prof. Dr · Children's Hospital at Uppsala University Hospital (Sweden)

  • Peter Le Souef, Prof. Dr. · Princess Margaret Hospital for Children (Australia)

  • Noel E Cranswick, Prof. Dr. · Royal Children's Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Years
Max Age
11 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2012-06-30
Completion
2012-06-30

Countries

  • Australia
  • Germany
  • Sweden

Study Locations

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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 NCT01081574 on ClinicalTrials.gov