Prospective, multicentric, international, randomised, double-blind trial in six parallel groups: 4 doses of the test product, active control and placebo. This study is intended to evaluate the efficacy and a dose response of V0114 (l-MEQUITAZINE) in a clinical situation with patients having a hay fever.
Conditions
Interventions
Product Name: V 0114
Product Code: V 0114
Pharmaceutical Form: Tablet
INN or Proposed INN: NA
Current Sponsor code: V0114
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration n
Sponsors
PIERRE FABRE MEDICAMENT
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with all the following criteria were eligible for enrolment: - 18 to 65 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 (May to July) with symptoms (sneezing and/or palate itching and/or aqueous rhinorrhea and/or nasal blockade) for at least two years, - a positive prick test to grass pollen grains, and/or class 3 or more specific IgE 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)- willing and able to understand and sign an approved Informed Consent Form,- able to understand the protocol and to attend the control visits,- 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 surgery, 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) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Non inclusion criteria:Patients with one of the following criteria were not eligible for enrolment:* 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,- Glaucoma or prostate adenoma,- History of agranulocytosis,- Congenital galactosemia, malabsorption syndrom to glucose or galactose, or galactase deficiency,- Seizure,- Asthma treated with corticosteroids,- Symptomatic allergic rhinitis out of the grass pollen season,- Iatrogenic rhinitis,- Nasal polyposis or severe deviation of the nasal septum, - 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 within the last 5 years,- Corticosteroid treatment within the last 6 months (delayed steroids) or within the last 4 weeks (local, inhaled or systemic routes), - Treatment by cromone or ketotifen within the last 2 weeks,- Treatment by 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 24 hours), tricyclic antidepressants (wash-out 1 month), MAO inhibitors (wash-out 1 month), atropine-like drugs (wash-out 1 month), any other treatment that could induce induction or inhibition of hepatic microsomial metabolism (wash-out period of 1 month).* Criteria related to the population- 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: - to evaluate the clinical efficacy of V0114 in the treatment of seasonal allergic rhinitis. - research of a dose-range effect. - evaluation of the different doses of V0114 versus placebo. - evaluation of the different doses of V0114 versus mequitazine 10 mg ;Secondary Objective: - to assess the systemic and biological tolerability of V0114 ;Primary end point(s): The nasal symptomatology of allergy will be quantified using a clinical score: nasal symptom score (NSS). It will be determined on the basis of 4 symptoms : sneezing, nose itching, rhinorrhea, nasal blockade. Each symptom will be rated on a four-grade scale: 0 = no sign, 1 = mild (intermittent without trouble), 2 = moderate (frequent with trouble), 3 = severe (continuous with trouble at work and during sleep). The clinical score will be the sum of these 4 symptom grades. The NSS will be evaluated by the investigator at Day 1, Day 7 and Day 14. The main criterion is the evolution of the Nasal Symptom Score (NSS) between D1 and D7 | — |
Countries
Czech Republic, Estonia, France
Outcome results
None listed