Perennial allergic rhinitis is a autoinmuno disease and its pathopshysiology is based on released of several mediators, such as histamine. The symptoms include: itchy eyes and palate, runny nose, sneezing and nasal obstruction. MedDRA version: 6 Level: pt Classification code 10039094
Conditions
Interventions
Trade Name: Rupafin 10 mg Tablets
Product Name: Rupatadine
Product Code: UR-12592
Pharmaceutical Form: Tablet
INN or Proposed INN: rupatadina fumarato
Concentration unit: mg milligram(s)
Concentratio
Sponsors
J. URIACH & COMPAÑIA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Men or women over the age of 12 2. Patients with a history of moderate-severe persistent allergic rhinitis for at least 12 months before the date of inclusion in the study (patients sensitized to pollens and moulds should be allowed to participate as long as they are not in a clinically relevant symptom phase). 3. Patients must undergo cutaneous prick test (+) for some allergen responsible for rhinitis. The test must be done the first day of inclusion unless the patient already has a prior prick test (+) for such allergens done in the 12 months prior to the date of inclusion. For the purposes of including a patient in the study, the prick test for a given allergen should be considered positive if the diameter of the papule obtained is at least 3 mm larger than the negative control. 4. Corrected Q-T interval values below 430 msec. in men and 450 msec. in women and an ECG with no clinically important abnormalities. No abnormality of cardiac rhythm, bradycardia below 55 beats/minute or history of cardiovascular disease. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) yes 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. Patients with non-allergic rhinitis (vasomotor, infectious, drug-induced, etc.). 2. Patients with allergic rhinitis sensitized to pollens and to moulds in acute symptom phase. 3. Negative cutaneous prick test 4. Patients with obstructive nasal polyps or a significant deviation of the nasal septum, at the investigator criterion. 5. Known hypersensitivity to piperazines (e.g. cetirizine, hydroxyzine) or piperidines (e.g. loratadine), other compounds structurally similar to study drug or any of the components of the study medicinal products. 6.Abnormal hematologic (total and differential blood cell counts) and biochemical values: serum glucose, electrolytes (sodium, potassium and chlorine), SGOT, SGPT, ?-GT, total bilirubin, alkaline phosphatase, total proteins, urea, creatinine, total cholesterol, triglycerides, CPK according to the normal reference values that, according to the investigator, are clinically significant.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: ? To assess long term safety of rupatadine 10 mg fumarate in the treatment of moderate-severe persistent allergic rhinitis in 12 months follow-up.;Secondary Objective: ;Primary end point(s): Percentatge of Serious Adverse Events | — |
Countries
Spain
Outcome results
None listed