A placebo-controlled, double-blind, cross-over study with rupatadine 10 mg in 30 mosquito-bite allergic adult subjectsRupatadiini-antihistamiini hyttyspistoallergiassa - Rupatadiini-antihistamiini hyttyspistoallergiassa
- Conditions
- mosquito-bite allergic adults
- Registration Number
- EUCTR2005-004422-50-FI
- Lead Sponsor
- J.Uriach y Compania S.A.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 30
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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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. <br><br>
- Secondary Outcome Measures
Name Time Method