EFFICACY AND SAFETY STUDY OF THE ANTIHISTAMINE V0114CP 2.5MG IN THE TREATMENT OF SEASONAL ALLERGIC RHINITIS. RANDOMISED, DOUBLE-BLIND, THREE ARM PARALLEL GROUP STUDY INCLUDING PLACEBO AND ACTIVE CONTROL ARM (DESLORATADINE 5 MG)
- Conditions
- The medical condition to be investigated in this study is the seasonal allergic rhinitis. The intended indication for the product is the treatment of allergic rhinitisMedDRA version: 9.1Level: LLTClassification code 10039777Term: Seasonal rhinitis
- Registration Number
- EUCTR2008-000133-22-BG
- Lead Sponsor
- Pierre Fabre Médicament
- 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:
- over 18 year-old male or female ambulatory patient,
- suffering from a seasonal allergic rhinitis to grass pollen grain defined by :
- a documented medical history of seasonal rhinitis during the grass pollen season (mainly 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 documented, the diagnosis will be assessed by the score for allergic rhinitis (SFAR),
- a positive skin prick test at least to grass 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 child bearing potential:
- use of an efficient contraceptive (implants, injectables, combined oral contraceptives, some intra-uterine devices or vasectomised partner related to note 3 of CPMP/ICH/286/95) for at least 2 months before the study and one month after the end of the study,
- 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
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, 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,
- Asthma requiring a corticosteroid treatment,
- Chronic alcoholism,
- History of agranulocytosis,
- Congenital galactosemia, malabsorption syndrom to glucose or galactose, or lactase deficiency,
- Seizure,
- Iatrogenic rhinitis,
- Nasal polyposis or severe deviation of the nasal septum,
- History of 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.
Non inclusion criteria (Ctd):* Criteria related to treatments
- Medical history of hypersensitivity to mequitazine or drug excipients,
-Failure to a previous treatment with desloratadine
- Specific desensitization to grass pollens finished within the last 6 months, whatever the issue,
- Depot corticosteroid treatment within the last 6 months,
- Oral, injectable (intramuscular, intravenous, intraarticular, intraspinal) corticosteroid treatment within the last 4 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 CYP2D6 (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 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: to demonstrate the efficacy of a 2-week treatment by the antihistamine V0114CP 2.5 mg versus placebo in reducing symptoms during seasonal allergic rhinitis.;Secondary Objective: to evaluate the clinical safety of V0114CP 2.5 mg. ;Primary end point(s): mean evolution during 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.<br>
- Secondary Outcome Measures
Name Time Method