EFFICACY AND SAFETY STUDY OF THE ANTIHISTAMINE V0114CP 2.5MG IN THE TREATMENT OF PERENNIAL ALLERGIC RHINITIS. RANDOMISED, DOUBLE-BLIND, THREE ARM PARALLEL GROUP STUDY INCLUDING PLACEBO AND ACTIVE CONTROL ARM (LEVOCETIRIZINE 5 MG)

• Register: EUCTR
• Last refreshed on: 29 May 2012
• Main ID: EUCTR2007-003572-19-EE
• Date of registration: 10/10/2007
• Prospective Registration: Yes
• Primary sponsor: Pierre Fabre Médicament
• Public title: EFFICACY AND SAFETY STUDY OF THE ANTIHISTAMINE V0114CP 2.5MG IN THE TREATMENT OF PERENNIAL ALLERGIC RHINITIS. RANDOMISED, DOUBLE-BLIND, THREE ARM PARALLEL GROUP STUDY INCLUDING PLACEBO AND ACTIVE CONTROL ARM (LEVOCETIRIZINE 5 MG)
• Scientific title: EFFICACY AND SAFETY STUDY OF THE ANTIHISTAMINE V0114CP 2.5MG IN THE TREATMENT OF PERENNIAL ALLERGIC RHINITIS. RANDOMISED, DOUBLE-BLIND, THREE ARM PARALLEL GROUP STUDY INCLUDING PLACEBO AND ACTIVE CONTROL ARM (LEVOCETIRIZINE 5 MG)
• Date of first enrolment: 04/12/2007
• Target sample size: 1080
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-003572-19
• 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: no Placebo: yes Other: no

Countries of recruitment

Austria, Czech Republic, Estonia, Finland, Latvia, Lithuania, Spain, United Kingdom

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 perennial allergic rhinitis (dust mite, animal dander, indoor moulds, cockroaches) defined by :
- a recorded medical history of perennial rhinitis with symptoms (sneezing and/or nasal 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 recorded, the clinical diagnosis will be assessed by the score for allergic rhinitis (SFAR),
NB: patients having episode(s) of symptomatic seasonal allergic rhinitis are eligible if the period 1 of the study (first 6 weeks) is performed out of the expected period(s) of the concerned seasonal allergens (e.g.: chestnut, grey alder, cypress, silver birch, mimosa, white ash, wall pellitory).
- a positive prick test and/or positive specific IgE (class ³3 or equivalent) to the concerned allergen(s) (dust mite, animal dander, cockroaches), duly documented in the medical file within the past 12 months,
- with an instantaneous morning nasal symptom score ³ 6 during at least 4 days during the 7 days before inclusion (maximal score: 12),
- in case of associated bronchial asthma, will be allowed only mild intermittent asthma, not requiring corticosteroids treatment,
- 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 contraceptive method (oral contraceptive, intra-uterine device, tubal ligature),
- 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 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,
- History of agranulocytosis,
- Congenital galactosemia, malabsorption syndrom to glucose or galactose, or lactase deficiency,
- Seizure,
- Severe nasal obtruction (score = 3),
- Iatrogenic rhinitis,
- Nasal polyposis or severe deviation of the nasal septum,
- History of nasal surgery,
- Acute or chronic rhinosinusitis, as defined by EP3OS guideline,
- 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 perennial allergens finished within the last 6 months, whatever the issue,
- Depot corticosteroid treatment within the last 6 months,
- Oral, intramuscular or intravenous corticosteroid treatment within the last 8 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 tricyclic antidepressants (wash-out 4 weeks), MAO inhibitors (wash-out 4 weeks), atropine-like drugs (wash-out 4 weeks).

Criteria related to the population
- poor compliance for fulfilling the diary during the selection period, as judged by the investigator,
- 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 intended indication for the product under development is the treatment of perennial allergic rhinitis.

Intervention(s)

Product Name: V0114
Product Code: V0114CP02A
Pharmaceutical Form: Tablet
Current Sponsor code: V0114CP02A
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: Xyzall
Pharmaceutical Form: Tablet
INN or Proposed INN: LEVOCETIRIZINE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-

Primary Outcome(s)

Main Objective: - to demonstrate the efficacy of a 6-week treatment by the antihistamine V0114CP 2.5 mg versus placebo in reducing symptoms during perennial allergic rhinitis.

Primary end point(s): evolution over the 6-week treatment period of the patient-rated instantaneous nasal symptom score NSS (sneezing, rhinorrhea, nose itching, nasal blockade) evaluated daily in the morning.
-Analysis of covariance on the NSS mean daily change over 6 weeks, with baseline NSS as a covariate (main analysis) in the FAS population.-Same analysis in the PP population.

Secondary Objective: - to evaluate the global assessment- to evaluate the clinical and biological safety of V0114CP 2.5 mg.

Secondary ID(s)

V00114 CP 302 2A