Efficacy and safety study of the antihistamine V0114CP 2.5mg in the treatment of seasonal allergic rhinitis randomized, double-blind, three arm parallel group study including placebo and active control arm (desloratadine 5 mg) - ND

• Register: EUCTR
• Last refreshed on: 7 August 2012
• Main ID: EUCTR2008-000133-22-IT
• Date of registration: 21/05/2008
• Prospective Registration: No
• Primary sponsor: PIERRE FABRE MEDICAMENT
• Public title: Efficacy and safety study of the antihistamine V0114CP 2.5mg in the treatment of seasonal allergic rhinitis randomized, double-blind, three arm parallel group study including placebo and active control arm (desloratadine 5 mg) - ND
• Scientific title: Efficacy and safety study of the antihistamine V0114CP 2.5mg in the treatment of seasonal allergic rhinitis randomized, double-blind, three arm parallel group study including placebo and active control arm (desloratadine 5 mg) - ND
• Date of first enrolment: 07/05/2008
• Target sample size: 900
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-000133-22
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: yes Other: no

Countries of recruitment

Belgium, Bulgaria, Czech Republic, Estonia, Germany, Hungary, Italy, Latvia, Lithuania, Poland, Spain

Key inclusion & exclusion criteria

Inclusion criteria:
- over 18 year-old male or female ambulatory patient, - suffering from seasonal allergic rhinitis to grass pollen, defined as: - 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 rhinorrhoea and/or nasal blockade) for at least 2 years; if, for 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 selection visit or duly documented in the medical file in the last 6 months, at least to grass pollen grains, - with a nasal symptomatology score rated by the patient equal or superior at 6 at inclusion (max. 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 at least 2 months before the study and one month after the end of 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

Exclusion criteria:
* 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. *Criteria related to treatments -medical history of hypersensitivity to mequitazine or drug exvipients, -specific desensitization to grass pollen 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, -treatment by antileukotriene within the last 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, -tratment by oxicams within the last 7 days, -regular treatment by nasal or oral decongetsive 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 -lenght 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 fofeited his(her freedom by administrative or legal award, or who is under guardianship, -subject who cannot be contacted in case of emergency. For women childbearing potential: -pregnancy of breast feeding.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Seasonal allergic rhinitis
MedDRA version: 9.1 Level: LLT Classification code 10001723 Term: Allergic rhinitis

Intervention(s)

Trade Name: AERIUS
Pharmaceutical Form: Tablet
INN or Proposed INN: Desloratadine
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use

Product Name: V0114
Product Code: V0114CP02A
Pharmaceutical Form: Tablet
INN or Proposed INN: L-MEQUITAZINE
Current Sponsor code: V0114
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2.5-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use

Primary Outcome(s)

Primary end point(s): mean evolution during the 14 days treatment period of the reflective (12 hours) patient-rated nasal symptoms score NSS (sneezing, rhinorrhea, nose itching, nasal blockade) evaluated daily in the evening

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

Secondary ID(s)

2008-000133-22-ES

V00014CP3042A