March 2010 By Faes Farma, S.A.
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.
||Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
|Ages Eligible for Study:||2 Years|
|Genders Eligible for Study:||Both|
|Accepts Healthy Volunteers:||No|
1. Either sex aged from ? 2 to < 12 years of age. Female subjects must not be of child
2. Height and weight within a majority range (e.g., 25th through 75th percentile) of the
subject's age and sex as provided in national tables.
3. Documented history of SAR/PAR or CU at the time of inclusion. Subjects must be
symptomatic at screening as judged by the investigator.
4. A documented positive skin prick test or IgE test (RAST) for at least one seasonal or
perennial allergen in children with AR obtained within the 12 months prior to
5. Excepting AR or CU, judged to be in general good health based on medical history,
physical examination and clinical laboratory tests, with a QTc duration on the ECG
recorded at screening within the normal range (? 440 msec).
6. Written informed consent signed by the legal representative of the minor (his/her
parent(s) or a person legally appointed if different from parent(s)) and, where
applicable, assent signed by the child, according to local regulations.
1. Female subjects of childbearing potential. If menarche occurs after study enrolment
and during the dosing period, the subject should be discontinued from the treatment
and followed up for safety as per protocol. Occurrence of menarche in the course of
the study should always be documented.
2. Intake of another investigational medication in another clinical study within 30 days
prior to the first study drug intake.
3. Clinically significant ECG abnormalities as judged by the investigator (e.g.,
Wolff-Parkinson-White [WPW] syndrome, long QT syndrome).
4. Known allergy/hypersensitivity to the study drug or its inactive ingredients.
5. Any clinical conditions or circumstances that in the opinion of the investigator
would make the subject unsuitable for the study (e.g., hepatic impairment, renal
impairment, mental impairment, cardiac disease).
6. Subjects with known positive Hepatitis B surface antigen (Hbs Ag), or Hepatitis C
antibody or who are known to be human immunodeficiency virus (HIV) positive. No
testing will be required for this study.
7. Subjects who are expected to take during the study period or have taken any of the
following medications prior to inclusion in the study and have not complied with the
specified wash out period of 7 days unless otherwise noted:
- Oral corticosteroids.
- Oral antihistamines: loratadine, desloratadine, and fexofenadine.
- Amoxicillin, benzylpenicillin, and macrolide antibiotics and imidazolic
- Aspirin, ibuprofen
- St. John's Wort (15 days)
8. Hypersensitivity to H1 antihistamines or benzimidazoles.
9. Ingestion of citrus fruits and cranberries or any fruit juice or any other well known
PgP or organic anion transporter polypeptide (OATP) inhibitor, inducer, or substrate
(see Appendix C) within 7 days prior to first dose of study medication.
10. Mentally disabled minors or Minors who by official order have been institutionalised
(e.g., in orphanages) must be excluded from participation.
11. Minors who explicitly refuse to take part in the study.