Study With Rupatadine in Mosquito-Bite Allergic Adult Subjects
Phase 4
- Conditions
- Allergy
- Registration Number
- NCT00258141
- Lead Sponsor
- J. Uriach and Company
- Brief Summary
The study will find out how effective rupatadine is in the treatment of mosquito bite symptoms in adult patients allergic to mosquito bites.
- Detailed Description
Mosquito-bite symptoms include wheals and pruritic bite papules. Oral antihistamines have shown to decrease whealing ang accompanying pruritus in placebo-controlled trials.
Subjects will be treated for 4 days, and exposed to experimental mosquito bite at day 3.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
- Recent history of suffering from mosquito-bite reactions.
- At least 5 mm diameter mosquito-bite wheal from Aedes aegypti laboratory mosquitoes
Exclusion Criteria
- Pregnancy or lactating females
- Oral antihistamines, corticosteroids or non-steroid anti-inflammatory drugs (NSAID) use within two weeks before the study.
- Severe or moderate systemic illness
- Allergy to rupatadine or other antihistamines
- Anaphylaxis from mosquito bites
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method Bite lesion size (squared mm)
- Secondary Outcome Measures
Name Time Method Pruritus on a Visual Analog Scale
Trial Locations
- Locations (2)
Ulappatorin Lääkäriasema
🇫🇮Espoo, Finland
Koskiklinikka, Tampere Lääkärikeskus
🇫🇮Tampere, Finland