Randomised, double-blind, placebo-controlled dose-effect study of V0114 (2.5, 5, 7.5 and 10 mg) versus mequitazine 10 mg and placebo in the treatment of seasonal allergic rhinitis.

Recruitment & Eligibility

Status: ot Recruiting

Sex: Not specified

Target Recruitment: 600

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

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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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