E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 6.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10039085 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
TO EVALUATE THE EFFECTS OF RUPATADINE 10 MG ON INFLAMMATORY PARAMETERS AFTER ALLERGEN CHALLENGE IN PATIENTS WITH PAR |
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E.2.2 | Secondary objectives of the trial |
TO ASSESS A REDUCTION OF SYMPTOMS INDUCED BY NASAL CHALLENGE AFTER TWO-WEEKS OF RUPATADINE 10 MG/PLACEBO TREATMENT |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal 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. |
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E.4 | Principal 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 |
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E.5 End points |
E.5.1 | Primary end point(s) |
TO EVALUATE THE EFFECTS OF RUPATADINE 10 MG ON INFLAMMATORY PARAMETERS AFTER ALLERGEN CHALLENGE IN PATIENTS WITH PAR |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 8 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 8 |