mosquito-bite allergic adults
Conditions
Interventions
Trade Name: Rupafin
Product Name: Rupatadine
Pharmaceutical Form: Tablet
INN or Proposed INN: Rupatadine
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Pharmac
Sponsors
J.Uriach y Compania S.A.,
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Mosquito-bite allergic subjects, mostly physicians, nurses and other health care personnel from the files of the investigators will be asked to participate in the study. Eligible subjects are defined by the following inclusion and exclusion criteria and a total of 30 subjects will included in the study. Inclusion criteria 1. Male or female, age 18 - 65 years. 2. History of suffering from mosquito-bite reactions and showing at inclusion at least 5 mm diameter wheal from Aedes aegypti laboratory mosquito bite. 3. Written informed consent to participate in the study. 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) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Exclusion criteria Assessed at screening, prior to randomization: 1. Pregnancy or lactating females 2. Oral antihistamines, corticosteroid or non-steroid anti-inflammatory drug (NSAID) use within two weeks before the study 3. Severe or moderate systemic illness 4. Anaphylaxis from mosquito bites 5. Allergy to rupatadine or other antihistamines
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The purpose of the present study is to examine how effective is prophylactically given rupatadine 10 mg against immediate and delayed symptoms caused by experimental mosquito bites in adult subjects allergic to the mosquito bites (ICD classification codes for patients: T14.0 bite of non-venomous insect and L50.0 urticaria). ;Secondary Objective: possible placebo effect ;Primary end point(s): Bite lesion size in mm2 (mean of the two bite lesions; calculated from two perpendicular diameters of the each bite lesion) and accompanying pruritus (VAS) measured under rupatadine and under placebo are compared in each subject with Wilcoxon's signed rank test with Hommel's adjusted P-value. Calculations will be performed separately for measurements at 15 min and at 24 h. | — |
Countries
Finland
Outcome results
None listed