CHIKUNGUNYA FEVER.
Conditions
Interventions
Trade Name: PRIMALAN
Product Name: Mequitazine
Product Code: L0013 CP 02A
Pharmaceutical Form: Tablet
INN or Proposed INN: Mequitazine
CAS Number: 29216-28-2
Current Sponsor code: L0013 CP 02A
Concent
Sponsors
PIERRE FABRE MEDICAMENT
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria: Will be included in the study those subjects who meet the following criteria: · Male and female patients aged more than 18 years; · Suspected of suffering from chikungunya fever whose the following criteria have appeared for =48 hours: o Arthritic pain involving of at least 2 peripheral joints; o Fever = 38°C o Cephalalgia. Other common criteria such as cutaneous eruption, myalgia can complete the clinical picture. NB: a further confirmation of the diagnosis will be obtained by laboratory analysis. Only patients with a serology-confirmed diagnosis will be conserved in the data sets to be analysed for efficacy; · Presence of a moderate to severe arthritis-like joint pain, defined as leading to a PI-NRS =4 on the most painful joint at first clinical examination; · Able to understand the protocol, to comply with its requirements and to attend to visits; · Able to give their written informed consent to participate in the study; · Subjects who, according to the judgment of the Investigator, are likely to be compliant during the study; · If required by national regulations, registered with a social security or health insurance system; · For women of childbearing potential, contraceptive method. 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
Exclusion criteria: Will not be included subjects who have at least one of the following criteria: · Criteria related to pathologies: o Who experience symptoms (fever or joint pain) from suspected chikungunya from > 48 hours; o History of proved chikungunya disease; o Past history of major medical, psychiatric disease or surgery which, in the judgment of the Investigator, could jeopardize their health or likely to modify their handling of the study drug; o Acute or chronic systemic disease or disorder; o Past history of hypersensitivity (abnormal drug reaction or idiosyncrasy or asthma) to mequitazine or its excipients; o Known narrow-angle glaucoma; o Known prostatic hypertrophy; o History of agranulocytosis; o Congenital galactosemia, glucose or galactose malabsorbtion syndrome, lactase deficiency; o Severe liver impairment; o Epileptic subject; o Any allergic disease (rhinitis, asthma, urticaria) requiring a continuous or discontinuous treatment; o Current ongoing infectious or rheumatoid disease or autoimmune disease; o Concomitant dengue infection. · Criteria related to treatments: o Treatment by a systemic anti-histamine drug within the previous 4 weeks; o Treatment by a systemic or local non-steroidal anti-inflammatory drugs (NSAIDs) within the previous week; o Treatment by depot corticosteroid treatment within the previous 6 months; o Treatment by oral or systemic corticosteroids within the previous 4 weeks; o Treatment by atropine or atropine-like drug within the previous week; o Treatment by a central nervous system depressant within the previous month; o Regular use of sedatives, hypnotics, tranquilizers or any illicit drug of abuse. · Criteria related to the way of life: o Known history of alcohol abuse (consumption > 28 units of alcohol / week); Known history of illicit drug of abuse. · Criteria related to the population: o Pregnancy or suspicion of pregnancy (for women of childbearing potential), breast feeding; o Known congenital or acquired immuno-deficiency; o Participation in another clinical trial during the previous month or planned participation during the study; o Subject who has forfeited his freedom by administrative or legal award, or who is under guardianship.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate in adults the efficacy of an early treatment by L0013CP 10 mg/day in comparison with placebo against painful arthritis symptoms experienced in chikungunya fever, over the first 7-day treatment period after the first symptoms.;Secondary Objective: To evaluate in adults the efficacy of an early treatment by mequitazine 10 mg/day in comparison with placebo against painful arthritis symptoms experienced in chikungunya fever over the first 14-day and the 28-day treatment period To evaluate in adults the efficacy of an early treatment by mequitazine 10 mg/day in comparison with placebo against possible dermatological symptoms (such as pruritus) and ophthalmologic symptoms experienced in chikungunya fever over the 28-day treatment period; To evaluate the quality of life (QoL) of patients suffering from chikungunya fever treated with mequitazine 10 mg/day in comparison with placebo, over the 28-day treatment period To evaluate the proportion of patients using paracetamol and the dose of paracetamol over the 28-day-treatment period To evaluate the proportion of patients responding to mequitazine 10 mg/day in comparison with those receiving the placebo, for painful symptoms of joint arthritis over the 28-day treatment period;Primary end point(s): Primary assessment criterion: Arthritis-like joint pain symptoms will be assessed through a 11-point numerical pain rating scale (PI-NRS, graded from 0 = no pain to 10 = worst possible pain) for joint pain (evaluated on the most painful joint) at rest at D0, then after 7 ± 1 days of treatment. For the primary efficacy criterion, the percentage change in PI-NRS score from baseline to 7 ± 1 days of treatment will be compared between mequitazine and placebo using an analysis of covariance (ANCOVA). Baseline PI-NRS score and country will be included in the model as covariates. | — |
Countries
France
Outcome results
None listed