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 | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10001726 |
E.1.2 | Term | Allergic rhinitis due to pollen |
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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 demonstrate the efficacy in adult patients 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: - male or female ambulatory patient, - no less than 18 year-old - suffering from a seasonal allergic rhinitis to grass and or weed pollen grain defined by : -- a documented medical history of seasonal rhinitis during the grass/weed pollen season (mainly April to October) 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 least to grass and or weed 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 childbearing potential: - use of an efficient contraceptive (implants, injectable, patch or combined oral contraceptives, some intra-uterine devices for at least 2 months before the study and one month after the end of the study, - negative urine pregnancy test at selection visit. |
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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, neuropsychiatric 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 (GINA II and higher), - Chronic alcoholism, - History of agranulocytosis, - Congenital galactosemia, malabsorption syndrome to glucose or galactose, or lactase deficiency, - Seizure, - Iatrogenic rhinitis, - Nasal polyposis or severe deviation of the nasal septum, - History of any 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. - Chronic neurologic or psychiatric diseases
*Criteria related to treatments: - Medical history of hypersensitivity to mequitazine or drug excipients, - Medical history of hypersensitivity to levocetirizine, to other piperazine derivatives, or to any of the excipients - Severe renal impairment at less than 10 ml/min creatinine clearance - Hereditary problems of galactose intolerance, glucose-galactose malabsorption, lactase deficiency - Failure to a previous treatment with levocetirizine, - Anti-allergy immunotherapy to grass and or weed pollens -- with increase of allergen challenges in the previous 2 years -- at any dose in the previous 6 months - Depot corticosteroid treatment within the last 6 months, - Oral, nasal, injectable (intramuscular, intravenous, intra-articular, intraspinal) corticosteroid treatment within the last 4 weeks, - Ocular, inhaled, potent or superpotent topical corticosteroid treatment within the last 2 weeks, - Treatment by antileukotriene within the 7 days, - Treatment by cromone or ketotifen within the last 1 week, - Treatment by H1 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 CYP2D6 inhibitors (fluoxetine, paroxetine, quinidine, thioridazine, clomipramine, haloperidol), - 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 linguistically or psychologically unable to understand the information given or formulate his/her informed consent or who refuses to give his/her consent in writing, - patient subject to an administrative or court order or subject to guardianship or wardship, - patient who cannot be contacted by telephone in an emergency. For women of childbearing potential: - pregnancy or breast feeding or planning a pregnancy during the course of the study. |
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E.5 End points |
E.5.1 | Primary end point(s) |
evolution over the 2-week treatment period of the patient-rated reflective 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 | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
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 | 12 |
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 | 0 |
E.8.9.1 | In the Member State concerned months | 7 |
E.8.9.1 | In the Member State concerned days | 0 |
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 | 7 |
E.8.9.2 | In all countries concerned by the trial days | 0 |