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Active (not recruiting) Phase 4 2024-519550-36-00

International multicentre, open-label, phase IV clinical trial to evaluate the efficacy, safety and effect on quality of life of bilastine in children with allergic rhinoconjunctivitis

Phase 4 – monitoring after market approval
Conditions: Allergic rhinoconjunctivitis

Sponsor: Faes Farma S.A., A. Menarini Industrie Farmaceutiche Riunite S.r.l.

trial.available_in: БГ
Overview
Trial status: Authorised Overall AR symptoms will be evaluated through the mean change of the T5CSS score measured at baseline (V1) and after 14 days (V3) of treatment by a participant’s e-diary
Who can participate
Age group: 0-17 years Gender: Female, Male Target enrollment: 70 participants
Interventions
Bilaxten Flas 10 mg comprimidos bucodispersables
Drug
Locations 3
Italy (1)
Poland (1)
Spain (1)
Technical details
Status
Active (not recruiting)
Phase
Phase 4
Study type
INTERVENTIONAL
Sex
Male and female
Healthy volunteers
No
Start date
19.01.2026
Registry ID
2024-519550-36-00
Source
euclinicaltrials.eu
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