E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
The intended indication for the product under development is the treatment of perennial 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 6-week treatment by the antihistamine V0114CP 2.5 mg versus placebo in reducing symptoms during perennial allergic rhinitis. |
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E.2.2 | Secondary objectives of the trial |
- to evaluate the global assessment- to evaluate the clinical and biological 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 perennial allergic rhinitis (dust mite, animal dander, indoor moulds, cockroaches) defined by : - a recorded medical history of perennial rhinitis with symptoms (sneezing and/or nasal 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 recorded, the clinical diagnosis will be assessed by the score for allergic rhinitis (SFAR), NB: patients having episode(s) of symptomatic seasonal allergic rhinitis are eligible if the period 1 of the study (first 6 weeks) is performed out of the expected period(s) of the concerned seasonal allergens (e.g.: chestnut, grey alder, cypress, silver birch, mimosa, white ash, wall pellitory). - a positive prick test and/or positive specific IgE (class ³3 or equivalent) to the concerned allergen(s) (dust mite, animal dander, cockroaches), duly documented in the medical file within the past 12 months, - with an instantaneous morning nasal symptom score ³ 6 during at least 4 days during the 7 days before inclusion (maximal score: 12), - in case of associated bronchial asthma, will be allowed only mild intermittent asthma, not requiring corticosteroids treatment, - 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 contraceptive method (oral contraceptive, intra-uterine device, tubal ligature), - negative urine pregnancy test. |
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E.4 | Principal exclusion criteria |
Criteria related to pathologies - Any cardio-vascular, renal, hepatic, gastro-intestinal, endocrine, haematological, neuro-psychiatric severe diseases that was not compatible with the participation to the study in the opinion of the investigator, - Any acute or chronic disease that did not allow with the participation to the study in the opinion of the investigator, - Chronic alcoholism, - History of agranulocytosis, - Congenital galactosemia, malabsorption syndrom to glucose or galactose, or lactase deficiency, - Seizure, - Severe nasal obtruction (score = 3), - Iatrogenic rhinitis, - Nasal polyposis or severe deviation of the nasal septum, - History of nasal surgery, - Acute or chronic rhinosinusitis, as defined by EP3OS guideline, - Upper respiratory tract infection within the last 3 weeks.
Criteria related to treatments - Medical history of hypersensitivity to mequitazine or drug excipients, - Specific desensitization to perennial allergens finished within the last 6 months, whatever the issue, - Depot corticosteroid treatment within the last 6 months, - Oral, intramuscular or intravenous corticosteroid treatment within the last 8 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 - poor compliance for fulfilling the diary during the selection period, as judged by the investigator, - 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) |
evolution over the 6-week treatment period of the patient-rated instantaneous nasal symptom score NSS (sneezing, rhinorrhea, nose itching, nasal blockade) evaluated daily in the morning. -Analysis of covariance on the NSS mean daily change over 6 weeks, with baseline NSS as a covariate (main analysis) in the FAS population.-Same analysis in the PP population. |
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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) | 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
| 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 | 100 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 200 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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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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The end of study is the date of the last visit (Visit 10) 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 | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |