Allergic Rhinitis MedDRA version: 12.1 Level: LLT Classification code 10001723 Term: Allergic rhinitis
Conditions
Interventions
Trade Name: Rupatadine
Product Name: Rupatadine
Pharmaceutical Form: Oral solution
INN or Proposed INN: RUPATADINE
CAS Number: 158876825
Concentration unit: mg milligram(s)
Concentration type: equal
C
Sponsors
J. Uriach y Compañía, S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1)Boys and girls between 2 and 5 years old, inclusive, at screening. (2)Weight 10 Kg. (3)Documented history of mild-moderate allergic rhinitis, susceptible to oral antihistamine treatment in the opinion of the investigator. (4)5TSS 6 during at least the last 2 days before inclusion. (5)Skin Prick test positive of 3 mm greater than the diluent control or a positive ImmunoCAP / RAST test. (6)Results of standard laboratory tests within acceptable limits as assessed by investigator. (7)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 450 msec. Are the trial subjects under 18? yes Number of subjects for this age range: 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
Exclusion criteria: (1) Clinically relevant abnormal physical findings which could interfere with the objectives of the study, or children with disabilities, developmental delay, psychological problems, or behavioural problems. (2) Clinically relevant abnormal laboratory values indicative of physical illness. (3) Ascertained of presumptive hypersensitivity to the active principle and/or formulation ingredients of the tested compounds such as children with lactose intolerance. (4) Children under any systemic or topical medication for AR and/or an inferior wash-out period as stated as follows: corticosteroids (oral and nasal 28 days, topical dermatological 14 days), cromones (14 days), 1st generation antihistamines, like chlorpheniramine, diphenhydramine, mequitazine or ocular, 7 days; 2nd generation, like loratadine, desloratadine, cetirizine, levocetirizine, 7 days, nasal decongestants (1-3 days), leukotriene inhibitors (3 days), herbal remedies (3 days), systemic antibiotics (14 days), anticholinergic (7 days), any potential inhibitor of CYP3A4 such as ketoconazole, erythromycin and/or tricyclic antidepressants, e.g. imipramin, amitriptilin, (28 days), ophthalmic non-steroidal anti-inflammatory drugs (3 days), nasal-ophthalmic wash solutions (12 h) and immunotherapy. Regular schedule immunotherapy can be maintained throughout the study but will be disallowed from 24h prior to first study dosing. Inhaled ?2 bronchodilators (salbutamol) or long acting (formoterol, salmeterol) are permitted. Children with mild asthma treated with inhaled corticosteroids of = 250 mcg/day for fluticasone ? 400 mcg/day for budesonide or ? 160 mcg/day for ciclesonide will be allowed in the study. (5) Children taking medication that is known to interact significantly with CYP3A4 isozyme of cytochrome P450 such as amiodarone, carbamazapine, cyclosporin, terfenadine, glucocorticoids, phenytoin, rifampicin, antivirals, erythromycin, ketoconazole as well as grapefruit juice. (6) Children that after review of their medical history, are considered by the investigator as unresponsive to antihistaminic treatment. (7) Children whose health could be harmed by their participation in the study at investigator criteria. (8) History of anaphylaxis to drugs or allergic reactions in general, which the Investigator considers may impact on the outcome of the study. (9) Relevant history of renal, hepatic, gastrointestinal, cardiovascular, respiratory, haematological, endocrine or neurological diseases that may interfere with the aim of the study. (10) History of chronic nasal or upper respiratory symptoms/disorders, nasal polyps and significant deviation of nasal septum. (11) History of non-allergic rhinitis (vasomotor, infectious, obstructive nasal polyposis, drug-induced, etc). (12) Chronic sinusitis or severe bronchial asthma. (13) Any ear, nose, or throat (ENT) infection in the last 15 days before the baseline visit or any associated ENT disease or temperature ? 38.5ºC at the baseline visit. (14) Children unable to comply with the study requirements (attendance to visits), unable (and their parents) to complete the patient diary and take the study treatment, or children who have to travel to another geographic area during the course of the study. (15) Children taking drugs strongly associated with torsade de pointes such as disopyramide, procainamide, quinidine, amiodarone, sotalol, thioridazine, beperidil or prenylamine.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the pharmacokinetics of rupatadine after the administration of multiple oral doses of rupatadine over a treatment period of 28 days in children between 2 and 5 years old with allergic rhinitis (AR). PK values as follows: volume of distribution of different compartments, total plasma clearance, intercompartmental clearance and absorption rate constant.;Secondary Objective: To evaluate efficacy, tolerability and safety after the administration of multiple oral doses of rupatadine over a treatment period of 28 days in children between 2 and 5 years old with allergic rhinitis (AR). •Change from baseline in the total score of the patient symptoms (5TSS) to Day 14 (end of treatment), and to Day 28. •Change in the daily score for each symptom (DSS) from baseline during 14 and 28 days. •Mean value of the daily total score of symptoms (mTSS). ;Primary end point(s): The main PK endpoint will be the evaluation of population PK, evaluated in terms of volume of distribution of different compartments, total plasma clearance, intercompartmental clearance and absorption rate constant | — |
Countries
Hungary
Outcome results
None listed