The intended indication for the product under development is the treatment of perennial allergic rhinitis.
Conditions
Interventions
Product Name: V0114
Product Code: V0114CP02A
Pharmaceutical Form: Tablet
Current Sponsor code: V0114CP02A
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2,5-
Pharm
Sponsors
Pierre Fabre Médicament
Eligibility
Sex/Gender
All
Inclusion criteria
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. 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: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - 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.;Secondary Objective: - to evaluate the global assessment- to evaluate the clinical and biological safety of V0114CP 2.5 mg. ;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. | — |
Countries
Austria, Czech Republic, Estonia, Finland, Latvia, Lithuania, Spain, United Kingdom
Outcome results
None listed