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Bilastine PK in Children with Allergic Rhinoconjunctivitis or Chronic Urticaria
NCT01081574Phase 2
Key facts
- Status
- Completed
- Start
- Jan 2010
- Primary completion
- Jun 2012
- Countries
- 3
- Sponsor
- Faes Farma
- Modality
- Small Molecules
- Drugs
- bilastine
- Conditions
- allergic rhinoconjunctivitis (ARC)chronic urticaria (CU)
01
Overview
Phase 2, open-label, single-arm trial of bilastine in allergic rhinoconjunctivitis (ARC) and chronic urticaria (CU), sponsored by Faes Farma. Primary endpoint: Pharmacokinetics of bilastine at Day 7. Started Jan 2010; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
10 mg Bilastine
10 mg Bilastine dispersible oral tablet once daily
03
Who it enrols
Children aged 2 to <12 years with documented history of SAR/PAR or CU, symptomatic at screening. Excludes females of childbearing potential, significant ECG abnormalities, and recent intake of interfering medications.
04
Endpoints
Primary
Pharmacokinetics of bilastine
Secondary
Safety and tolerability of repeated administration
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