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)

• Register: EUCTR
• Last refreshed on: 5 August 2013
• Main ID: EUCTR2008-001860-36-SK
• Date of registration: 09/04/2008
• Prospective Registration: Yes
• Primary sponsor: Pierre Fabre Médicament
• Public title: 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)
• Scientific title: 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)
• Date of first enrolment: 29/05/2008
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-001860-36
• 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

Slovakia

Key inclusion & exclusion criteria

Inclusion criteria:
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, injectable, patch or combined oral contraceptives,
some intra-uterine devices as 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

Exclusion criteria:
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,
- 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 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 excipients,
- Failure to a previous treatment with desloratadine,
- Specific desensitisation to grass pollens finished within the last 6 months, whatever the issue,
- Depot corticosteroid treatment within the last 6 months,
- Oral, injectable (intramuscular, intravenous, intra-articular, 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 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 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.


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

Health Condition(s) or Problem(s) studied

The medical condition to be investigated in this study is the seasonall allergic rhinitis. The intendent indication for the product is the treatment of allergic rhinitis.

Intervention(s)

Product Name: V0114
Product Code: V0114CP02A
Pharmaceutical Form: Tablet
Current Sponsor code: V0114
Other descriptive name: L-MEQUITAZINE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2,5-
Pharmaceutical form of the placebo: Capsule*
Route of administration of the placebo: Oral use

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

Primary Outcome(s)

Secondary Objective: to evaluate the clinical safety of V0114CP 2,5 mg

Primary end point(s): evolution over the 2-week treatment period of the patient-rated reflective
nasal symptom 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 mgversus placebo in reducing symptoms during seasonall allergic rhinitis

Secondary ID(s)

V00114CP3042A