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Study With Rupatadine in Mosquito-Bite Allergic Adult Subjects

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

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00258141
Enrollment
30
Registered
2005-11-24
Start date
Unknown
Completion date
Unknown
Last updated
2005-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allergy

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.

Interventions

DRUGPlacebo

Sponsors

J. Uriach and Company
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
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

Design outcomes

Primary

MeasureTime frame
Bite lesion size (squared mm)

Secondary

MeasureTime frame
Pruritus on a Visual Analog Scale

Countries

Finland

Contacts

Primary ContactTimo Reunala, Prof.
timo.reunala@uta.fi(+358) 331165167

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026