Efficacy compared between bilastine, desloratadine, rupatadine and placebo in reduction of histamine-induced skin reactivity in healthy volunteers.
- Conditions
- ALLERGIC RHINOCONJUNTIVITIS AND CHRONIC URTICARIATherapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- EUCTR2015-000790-13-ES
- Lead Sponsor
- FAES FARMA, S.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
1 Subjects of either gender (male or female) with an age between 18 and 40 years (both included). 2 Body weight within the normal range (BMI between18 and 30 kg/m2. 3 Medical history, physical examination by organs, both within normal limits. 4 No evidence of significant disease (organic or psychiatric) based on anamnesis taking, physical examination and complementary tests. 5 Laboratory tests (complete blood count and chemistry) within the normal ranges according to the normal reference values of the chemistry laboratory of the Hospital de la Santa Creu i Sant Pau. Variations may be admitted in accordance with the CIM's clinical criterion. 6 Vital signs (systolic and diastolic blood pressure, heart rate and temperature) and ECG record within normal ranges. 7 Child-bearing potential female volunteers must use contraceptive measures other than hormonal contraceptives. 8 Induced wheal area values within the reference range of the Research Institute (55.21 mm2-259.41 mm2), in the histamine skin reaction test performed during the selection. 9 Free will to participate in the study, with written informed consent signed.
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 24
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1 Background of allergy, idiosyncrasy or hypersensitivity to drugs. 2 Heavy consumer of stimulating drinks (>5 cups of coffee, tea, chocolate or cola drinks per day). 3 Background of alcoholism or drug dependence in the last one year or daily consumption of alcohol >40 gr/day for men or 24 gr/day for women. 4 Use of any medication within 2 weeks prior to taking the study treatment, (except for the use of paracetamol in short-term symptomatic treatments) including over-the-counter medications and medicinal plants. 5 Positive serology for hepatitis B, C or HIV. 6 Positive results for abuse drugs urine test or ethanol in breath test. 7 Background or clinical evidence of cardiovascular, respiratory, renal, hepatic, endocrine, gastrointestinal, haematological, neurological disease or other chronic diseases. 8 Rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactosemalabsorption. 9 Smokers. 10 Pregnancy or lactation status. 11 To have participated in another clinical trial during the 3 months prior to study starts. 12 To have donated blood in the 4 weeks prior to study starts. 13 To have underground major surgery during the previous 6 months. 14 Positive dermographism.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: TO COMPARE THE EFFICACY OF BILASTINE 20 MG, DESLORATADINE 5 MG AND RUPATADINE 10 MG IN THE REDUCTION OF HISTAMINE-INDUCED SKIN REACTIVITY IN HEALTHY VOLUNTEERS.;Secondary Objective: TO EVALUATE THE SUBJETIVE FEELING OF ITCHING AFTER HISTAMINE INOCULATION AND THE ONSET OF ACTION FOR EVERY TREATMENT VERSUS PLACEBO. <br>TO EVALUATE THE TOLERABILITY AND SAFETY OF PRODUCTS.;Primary end point(s): The porcentage (%) of reduction of the wheal and flare areas obtained after study drug administrations in comparison to their corresponding baseline values in cm3.<br>The following formula will be used:<br>% reduction=[(postdose value - baseline value) x 100] / baseline value;Timepoint(s) of evaluation of this end point: From the administration of the treatment up to 24 hour after, each one of the formulations.
- Secondary Outcome Measures
Name Time Method