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, ECG 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, 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 - QTc interval > 450 ms - 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. Note. The treatment will be stopped at the end of Period 3 (Week 52). Any continuation of the study beyond this point will be subject to a substantial amendment . |
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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 |