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NCT00258141 Clinical Trial

Study With Rupatadine in Mosquito-Bite Allergic Adult Subjects

Allergy Clinical Trial

Official title:
A Placebo-Controlled, Double-Blind, Cross-Over Study With Rupatadine 10 Mg in 30 Mosquito-Bite Allergic Adult Subjects

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT00258141
Other study ID # DM03RUP/IV/05
Secondary ID
Status Not yet recruiting
Phase Phase 4
First received November 23, 2005
Last updated November 23, 2005

Study information
Verified date November 2005
Source J. Uriach and Company
Contact Timo Reunala, Prof.
Phone (+358) 331165167
Email timo.reunala@uta.fi
Is FDA regulated No
Health authority Finland: Finnish Medicines Agency
Study type Interventional

Clinical Trial Summary

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

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 information / eligibility
Status Not yet recruiting
Enrollment 30
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Drug:
• Rupatadine

• Placebo

Locations
Country Name City State
Finland Ulappatorin Lääkäriasema Espoo
Finland Koskiklinikka, Tampere Lääkärikeskus Tampere

Sponsors (1)
Lead Sponsor Collaborator
J. Uriach and Company

Country where clinical trial is conducted

Finland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Bite lesion size (squared mm)
Secondary Pruritus on a Visual Analog Scale
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