Study With Rupatadine in Mosquito-Bite Allergic Adult Subjects

Uriach

Status and phase: Unknown; Phase 4

Conditions: Allergy

Treatments: Drug: Rupatadine; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00258141

DM03RUP/IV/05

Details and patient eligibility

About

The study will find out how effective rupatadine is in the treatment of mosquito bite symptoms in adult patients allergic to mosquito bites.

Full 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.

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind