E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
The medical condition to be investigated in this study is the seasonal allergic rhinitis. The intended indication for the product is the treatment of allergic rhinitis |
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MedDRA Classification |
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 demonstrate the efficacy of a 2-week treatment by the antihistamine V0114CP 2.5 mg versus placebo in reducing symptoms during seasonal allergic rhinitis. |
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E.2.2 | Secondary objectives of the trial |
to evaluate the clinical safety of V0114CP 2.5 mg. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients with all the following criteria will be eligible for enrolment: - over 18 year-old male or female ambulatory patient, - suffering from a seasonal allergic rhinitis to grass pollen grain defined by : - a documented medical history of seasonal rhinitis during the grass pollen season (mainly May to July) with symptoms (sneezing and/or palate itching and/or aqueous rhinorrhea and/or nasal blockade) for at least two years; if, for a new patient, the medical history has never been documented, the diagnosis will be assessed by the score for allergic rhinitis (SFAR), - a positive skin prick test at selection visit, at least to grass pollen grains, at selection visit or duly documented in the medical file within the last 6 months - with a nasal symptomatology score rated by the patient equal or superior to 6 at inclusion (maximal score: 12), - willing and able to understand and sign an approved Informed Consent Form, - able to understand the protocol and to attend the control visits, - if required by national regulation, registered with a social security or health insurance system.
For women of child bearing potential: - use of an efficient contraceptive (implants, injectables, combined oral contraceptives, some intra-uterine devices related to note 3 of CPMP/ICH/286/95) for at least 2 months before the study and one month after the end of the study, - negative urine pregnancy test. |
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E.4 | Principal exclusion criteria |
Patients with one of the following criteria will not be eligible for enrolment:
* Criteria related to pathologies - Any cardio-vascular, renal, hepatic, gastro-intestinal, endocrine, haematological, neuro-psychiatric severe diseases that will not be compatible with the participation to the study in the opinion of the investigator, - Any acute or chronic disease that will not allow with the participation to the study in the opinion of the investigator, - Asthma requiring a corticosteroid treatment, - Chronic alcoholism, - History of agranulocytosis, - Congenital galactosemia, malabsorption syndrom to glucose or galactose, or lactase deficiency, - Seizure, - Iatrogenic rhinitis, - Nasal polyposis or severe deviation of the nasal septum, - History of nasal surgery within the last 6 months, - Acute or chronic rhinosinusitis, as stated by the epidemiological definition of the EP3OS guideline, - Upper respiratory tract infection within the last 3 weeks. Non inclusion criteria (Ctd):* Criteria related to treatments - Medical history of hypersensitivity to mequitazine or drug excipients, - Specific desensitization to grass pollens finished within the last 6 months, whatever the issue, - Depot corticosteroid treatment within the last 6 months, - Oral, injectable (intramuscular, intravenous, intraarticular, intraspinal) corticosteroid treatment within the last 4 weeks, - Nasal or ocular corticosteroid treatment within the last 4 weeks, - Inhaled corticosteroid treatment within the last 4 weeks, - Potent and/or superpotent topical corticosteroid within the last 4 weeks, - Treatment by antileukotriene within the 7 days, - Treatment by cromone or ketotifen within the last 2 weeks, - Treatment by antihistamine within the last 7 days, by loratadine within the last 10 days, - Treatment by NSAIDs (other than oxicams) within the last 3 days, - Treatment by oxicams within the last 7 days, - Regular treatment by nasal or oral decongestive drug within the last 7 days, - Treatment by tricyclic antidepressants (wash-out 4 weeks), MAO inhibitors (wash-out 4 weeks), atropine-like drugs (wash-out 4 weeks).
* Criteria related to the population - length of QTc interval > 450 ms, - planned travel outside the study area for a substantial portion of the study period, - participation to another clinical trial in the previous month or during the study, - patient who, in the judgement of the investigator is not likely to be compliant during the study, - patient who has forfeited his/her freedom by administrative or legal award, or who is under guardianship, - subject who cannot be contacted in case of emergency.
For women of childbearing potential: - pregnancy or breast feeding.
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E.5 End points |
E.5.1 | Primary end point(s) |
mean evolution during the 14 days treatment period of the reflective (12 hours) patient-rated nasal symptom score NSS (sneezing, rhinorrhea, nose itching, nasal blockade) evaluated daily in the evening.
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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 | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
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) | Yes |
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
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 7 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 140 |
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 | No |
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
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 5 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 5 |