Clinical trial in children from 2 to 11 years with either allergic rhinonconjuctivitis or chronic urticaria in order to evaluate the safety and tolerability of 10 mg once daily bilastine

• Conditions: Allergic Rhinoconjunctivitis and Chronic Urticaria; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2012-003506-27-PT
• Lead Sponsor: FAES FARMA, S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-12-28
• Last Update Posted: 8 December 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 504

Inclusion Criteria

(1) Boys and girls between 2 and 11 years old, inclusive, at screening.
(2) Documented history of allergic rhinoconjunctivitis (AR) or chronic urticaria (CU) with clinical symptoms at study entry.
(3) For AR patients, a positive skin prick test/RAST for at least one allergen.
(4) A 12 lead ECG obtained at screening within acceptable limits, moreover in absence of any drug effect or disease, QTc interval values (msec) after Fridericia’s correction must be normal (not prolonged). The values considered to be normal are lower than 440 msec.
(5) Children who have written consent from their parent(s)/guardian to participate in the study. Children should be informed according to their understanding (assent form will be obtained whenever possible).
Are the trial subjects under 18? yes
Number of subjects for this age range: 504
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

(1) Non-allergic rhinitis or acute urticaria.
(2) Intake of particular medications with antiallergenic activities or sedative properties.
(3) Known allergy/hypersensitivity to the study drug (bilastine) or its inactive ingredients.
(4) Patients who are taking or have taken any of the following medications prior to randomisation in the study and have not complied with the specified washout period of 7 days unless otherwise noted:
• Oral corticosteroids.
• Antihistamines: Loratadine/ desloratadine (10 days) other systemic antihistamines (3 days).
• Anti-leukotrienes.
• Delayed-release corticosteroids (3 months).
• Ketotifen (2 weeks).
• Macrolides antibiotics and imidazolic antifungals (systemic).
• Anticholinergics.
• Investigational medication or antibodies.
• Regular schedule immunotherapy can be maintained throughout the study but will be disallowed from 24h prior to 24h after first study dosing.
(5) Clinically relevant abnormal laboratory values indicative of physical illness (including clinically significant ECG abnormalities as judged by the investigator; e.g. Wolff-Parkinson-White syndrome or long QT syndrome), or patient whose health could be harmed by their participation in the study at investigator criteria.
(6) Hypersensitivity to H1 antihistamines or benzimidazoles.
(7) Any clinical conditions or relevant history of renal, hepatic, gastrointestinal, cardiovascular, respiratory, haematological, endocrine or neurological diseases that in the opinion of the investigator would make the subject unsuitable for the study or interfere with the aim of the study.
(8) Children or parent(s) unable to comply with the study requirements (attendance to visits), unable to take the study treatment, or children that should have to travel to another geographic area during the course of the study.
(9) Girl who is pregnant or lactating.
(10) Children who have a recent history (within previous 12 months) of drug addiction or alcohol abuse.
(11) Participation in another clinical study within 30 days prior to the first study drug intake.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified