PAR MedDRA version: 6.1 Level: PT Classification code 10039085
Conditions
Interventions
Product Name: RUPAFIN
Pharmaceutical Form: Tablet
INN or Proposed INN: Rupatadine
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the pl
Sponsors
URIACH J. URIACH Y COMPANIA S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: PATIENT AGREEING TO PARTICIPATE BY SIGNING THE INFORMED CONSENT FORM MALE OR FEMALE AGE OR EQUAL 18 AND OR EQUAL 65 PATIENTS WITH A CLINICAL HISTORY OF PERSISTENT ALLERGIC RHINOCONJUNCTIVITIS ACCORDING TO ARIA GUIDELINES 12 FROM AT LEAST 1 YEAR POSITIVE SKIN PRICK TEST OR RAST AT LEAST CLASS II FOR PARIETARIA JUDAICA LABORATORY BIOCHEMICAL AND HEMATOLOGY RESULTS WITHIN NORMAL RANGES. IF THE PATIENT HAS A RESULT OUTSIDE OF THESE RANGES, IN ORDER TO BE INCLUDED, THE RESEARCHER SHOULD CONSIDER IT NOT CLINICALLY SIGNIFICANT. Are the trial subjects under 18? no 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: PREGNANCY, BREAST FEEDING, OR OF CHILDBEARING POTENTIAL FEMALES WHO ARE NOT USING A MEDICALLY ACCEPTED CONTRACEPTIVE METHOD CLINICALLY SIGNIFICANT SENSITISATION TO ALLERGENS OTHER THAN PARIETARIA JUDAICA CAT AND DOG ALLOWED IF PATIENTS HAVE NO PETS AT HOME , KNOWN HYPERSENSITIVITY TO THE STUDY DRUG OR TO COMPOUNDS WITH A SIMILAR STRUCTURE OR TO ANY OF ITS COMPONENTS, SUCH AS LACTOSE-INTOLERANT PATIENTS. ASTHMATICS PATIENTS DISEASES REQUIRING TREATMENT WITH CORTICOSTEROIDS ASSOCIATED ENT DISEASES VASOMOTOR RHINITIS, NASAL POLYPOSIS, SEVERE DEVIATION OF NASAL SEPTUM, SINUSITIS COEXISTENCE OF OTHER CLINICALLY SIGNIFICANT DISEASE PATIENTS TAKING MEDICATION THAT INTERACTS WITH ISOENZYME CYP3A4 OF CYTOCHROME P45O AS IS THE CASE OF AMIODARONE, CARBAMAZEPINE, CYCLOSPORINE, TERFENADINE, GLUCOCORTICOIDS, PHENYTOIN, RIFAMPICIN, ERYTHROMYCIN AND KETOCONAZOLE AS WELL AS GRAPEFRUIT JUICE. PATIENTS CONSIDERED NON-RESPONSIVE TO ANTIHISTAMINE TREATMENT BY THE RESEARCHER, AFTER REVIEWING THE CASE HISTORY. PATIENTS WITH PSYCHIATRIC, VASCULAR, HEPATIC, RENAL, NEUROLOGIC, ENDOCRINE OR OTHER SYSTEMIC DISEASE AS WELL AS PATIENTS WHO, IN THE RESEARCHERS JUDGMENT, ENCUMBER THE APPLICATION OF THE PROTOCOL OR THE INTERPRETATION OF THE RESULTS OF THE STUDY. PATIENTS WHO MANIPULATE HEAVY MACHINERY OR DRIVE VEHICLES AS A FUNDAMENTAL PART OF THEIR JOB. PATIENTS WHO TAKE DRUGS STRONGLY ASSOCIATED WITH TORSADE DE POINTES SUCH AS DISOPYRAMIDE, PROCAINAMIDE, QUINIDINE, AMIODARONE, SOTALOL, THIORIDAZINE, BEPRIDIL OR PRENYLAMINE. PARTICIPATION TO CLINICAL TRIALS IN THE LAST 3 MONTHS PATIENTS CURRENTLY OR FORMERLY ABUSING ALCOHOL OR ILLICIT DRUGS PATIENTS OVER OR UNDER 40 NORMAL WEIGHT ACCORDING TO STANDARD BMI. PATIENTS WHO UNDERWENT NASAL SURGERY IN THE PAST 6 MONTHS PATIENTS WHO RECEIVED SPECIFIC IMMUNOTHERAPY LAST INTAKE AT LEAST 5 YEARS SINCE V1
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: TO EVALUATE THE EFFECTS OF RUPATADINE 10 MG ON INFLAMMATORY PARAMETERS AFTER ALLERGEN CHALLENGE IN PATIENTS WITH PAR;Secondary Objective: TO ASSESS A REDUCTION OF SYMPTOMS INDUCED BY NASAL CHALLENGE AFTER TWO-WEEKS OF RUPATADINE 10 MG/PLACEBO TREATMENT;Primary end point(s): TO EVALUATE THE EFFECTS OF RUPATADINE 10 MG ON INFLAMMATORY PARAMETERS AFTER ALLERGEN CHALLENGE IN PATIENTS WITH PAR | — |
Countries
Italy
Outcome results
None listed