NCT00258141UnknownPhase 4
A Placebo-Controlled, Double-Blind, Cross-Over Study With Rupatadine 10 Mg in 30 Mosquito-Bite Allergic Adult Subjects
J. Uriach and Company3 sites in 1 country30 target enrollmentStarted: November 24, 2005Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Sponsor
- Enrollment
- 30
- Locations
- 3
- Primary Endpoint
- Bite lesion size (squared mm)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Prevention
- Masking
- Double
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Bite lesion size (squared mm)
Secondary Outcomes
- Pruritus on a Visual Analog Scale
Investigators
Study Sites (3)
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