E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
ALLERGIC RHINITIS
prospective, multicentric, international, randomised, double-blind trial in two parallel groups: V0114CP 2.5 mg tablet versus placebo.
This study is planned to assess the efficacy of V0114CP 2.5 mg in symptoms relief during seasonal 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 |
Objectives : Primary : - to demonstrate the efficacy of a 2-week treatment by the antihistamine V0114CP 2.5 mg in reducing symptoms during seasonal allergic rhinitis. |
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E.2.2 | Secondary objectives of the trial |
Objectives : Secondary: - to evaluate the percentage of success to treatment - to evaluate the onset of action - to evaluate the clinical global improvement - to evaluate the systemic tolerance of V0114CP 2.5 mg. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Inclusion criteria: Patients with all the following criteria will 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 recorded medical history of seasonal rhinitis during the grass pollen season (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 recorded, the diagnosis will be assessed by the score for allergic rhinitis (SFAR), - a positive prick test to grass pollen grains, and/or positive specific IgE (class ³3 or equivalent) duly documented in the medical file within the past 6 months, - with a nasal symptomatology score equal or superior to 6 at inclusion (maximal score: 12),
- in case of associated bronchial asthma, will be allowed only mild intermittent asthma, not requiring systemic corticosteroids or whose use of inhaled corticosteroids has not been changed within the last month, - 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, double barrier method: spermicide gel + condom). |
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E.4 | Principal exclusion criteria |
Exclusion criteria: 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, - Chronic alcoholism, - History of agranulocytosis, - Congenital galactosemia, malabsorption syndrome to glucose or galactose, or lactase deficiency, - Seizure, - Iatrogenic rhinitis, - Nasal polyposis or severe symptomatic deviation of the nasal septum, - History of nasal surgery in the previous 6 months, - Documented evidence of acute or significant chronic sinusitis, - 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 grass pollens finished within the last 12 months whatever the issue, - Corticosteroid treatment within the last 6 months (delayed steroids) or within the last 4 weeks (oral, intravenous, nasal, potent or super-potent cutaneous), - Treatment by antileukotriene within the last 2 weeks, - Treatment by local or oral cromone or ketotifen within the last 2 weeks, - Treatment by local or oral antihistamine within the last 2 weeks, - Treatment by NSAIDs (other than oxicams) within the last three days, - Treatment by oxicams within the last 8 days, - Treatment by nasal or systemic decongestive drug: wash-out of 4 weeks if regular use, of 72 hours if intermittent use, - Treatment by tricyclic antidepressants, MAO inhibitors, atropine-like drugs within the last month.
* Criteria related to the population - 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: - Pregnancy or breast feeding.
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E.5 End points |
E.5.1 | Primary end point(s) |
Efficacy: Primary criterion : evolution over 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.
The primary efficacy criterion is the change from baseline of the reflective patient-rated nasal symptom score (sneezing, rhinorrhea, nose itching, nasal blockade) evaluated daily in the evening, recording by the optic pens, over the 2-week treatment period.
Primary analysis
The primary efficacy analysis will use a likelihood-based Mixed-effects Model for Repeated Measures (MMRM) on the patient-rated reflective nasal symptom score change from baseline to week 2 (D14) and will be performed on the FAS with observed case (OC) approach. The model will include Treatment, Centre and Visits as main effects, baseline reflective NSS score as covariate.
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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.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 90 |
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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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 | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 6 |