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.
Conditions
Interventions
Product Code: V0114CP
Pharmaceutical Form: Tablet
Current Sponsor code: V0114
Other descriptive name: L-MEQUITAZINE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number:
Sponsors
PIERRE FABRE MEDICAMENT
Eligibility
Sex/Gender
All
Inclusion criteria
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). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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.;Secondary Objective: 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. ;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. | — |
Countries
Czech Republic, Estonia, France, Lithuania
Outcome results
None listed