A DOUBLE BLIND, RANDOMISED, PARALLEL, PLACEBO-CONTROLLED, PILOT STUDY TO EVALUATE THE ANTI-INFLAMMATORY EFFECTS AND THE EFFICACY OF RUPATADINE 10 MG ON THE SYMPTOMS OF PERSISTENT ALLERGIC RHINITIS - ND

RIACH J. URIACH Y COMPANIA S.A.0 sites30 target enrollmentJanuary 15, 2007

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Not specified
Sponsor: RIACH J. URIACH Y COMPANIA S.A.
Enrollment: 30
Status: Active, not recruiting
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

January 15, 2007

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

RIACH J. URIACH Y COMPANIA S.A.

Eligibility 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

•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