EFFICACY AND SAFETY STUDYOF THE ANTIHISTAMINE V0114CP 2.5MGIN THE TREATMENT OF SEASONAL ALLERGIC RHINITIS.RANDOMISED, DOUBLE-BLIND, THREE ARM PARALLEL GROUP STUDYINCLUDING PLACEBO AND ACTIVE CONTROL ARM (LEVOCETIRIZINE 5 MG).
- Conditions
- Allergic rhinitisMedDRA version: 9.1Level: LLTClassification code 10001726Term: Allergic rhinitis due to pollen
- Registration Number
- EUCTR2008-008734-36-DE
- Lead Sponsor
- PIERRE FABRE MEDICAMENT
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 900
Patients with all the following criteria will be eligible for enrolment:
- male or female ambulatory patient,
- no less than 18 year-old
- suffering from a seasonal allergic rhinitis to grass and or weed pollen grain defined by :
-- a documented medical history of seasonal rhinitis during the grass/weed pollen season (mainly April to October) 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 documented, the diagnosis will be assessed by the score for allergic rhinitis (SFAR),
-- a positive skin prick test at least to grass and or weed pollen grains, at selection visit or duly documented in the medical file within the last 6 months,
-- with a nasal symptomatology score rated by the patient 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
- if required by national regulation, registered with a social security or health insurance system.
For women of childbearing potential:
- use of an efficient contraceptive (implants, injectable, patch or combined oral contraceptives, some intra-uterine devices for at least 2 months before the study and one month after the end of the study,
- negative urine pregnancy test at selection visit.
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
Patients with one of the following criteria will not be eligible for enrolment:
* Criteria related to pathologies:
- Any cardio-vascular, renal, hepatic, gastro-intestinal, endocrine, haematological, neuropsychiatric 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,
- Asthma requiring a corticosteroid treatment (GINA II and higher),
- Chronic alcoholism,
- History of agranulocytosis,
- Congenital galactosemia, malabsorption syndrome to glucose or galactose, or lactase deficiency,
- Seizure,
- Iatrogenic rhinitis,
- Nasal polyposis or severe deviation of the nasal septum,
- History of any nasal surgery within the last 6 months,
- Acute or chronic rhinosinusitis, as stated by the epidemiological definition of the EP3OS guideline,
- Upper respiratory tract infection within the last 3 weeks.
- Chronic neurologic or psychiatric diseases
*Criteria related to treatments:
- Medical history of hypersensitivity to mequitazine or drug excipients,
- Medical history of hypersensitivity to levocetirizine, to other piperazine derivatives, or to any of the excipients
- Severe renal impairment at less than 10 ml/min creatinine clearance
- Hereditary problems of galactose intolerance, glucose-galactose malabsorption, lactase deficiency
- Failure to a previous treatment with levocetirizine,
- Anti-allergy immunotherapy to grass and or weed pollens
-- with increase of allergen challenges in the previous 2 years
-- at any dose in the previous 6 months
- Depot corticosteroid treatment within the last 6 months,
- Oral, nasal, injectable (intramuscular, intravenous, intra-articular, intraspinal) corticosteroid treatment within the last 4 weeks,
- Ocular, inhaled, potent or superpotent topical corticosteroid treatment within the last 2 weeks,
- Treatment by antileukotriene within the 7 days,
- Treatment by cromone or ketotifen within the last 1 week,
- Treatment by H1 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 CYP2D6 inhibitors (fluoxetine, paroxetine, quinidine, thioridazine, clomipramine, haloperidol),
- 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:
- length of QTc interval > 450 ms,
- 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 linguistically or psychologically unable to understand the information given or formulate his/her informed consent or who refuses to give his/her consent in writing,
- patient subject to an administrative or court order or subject to guardianship or wardship,
- patient who cannot be contacted by telephone in an emergency.
For women of childbearing potential:
- pregnancy or breast feeding or planning a pregnancy during the course of the study.
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