Study With Rupatadine in Mosquito-Bite Allergic Adult Subjects

NCT ID: NCT00258141

Last Updated: 2005-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Brief Summary

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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

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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.

Conditions

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Allergy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Interventions

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Rupatadine

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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J. Uriach and Company

INDUSTRY

Sponsor Role lead

Principal Investigators

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Timo Reunala, Prof.

Role: PRINCIPAL_INVESTIGATOR

Medical School, University of Tampere and Tampere University Hospital

Locations

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Ulappatorin Lääkäriasema

Espoo, , Finland

Site Status

Koskiklinikka, Tampere Lääkärikeskus

Tampere, , Finland

Site Status

Countries

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Finland

Central Contacts

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Timo Reunala, Prof.

Role: CONTACT

Phone: (+358) 331165167

Email: [email protected]

Other Identifiers

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DM03RUP/IV/05

Identifier Type: -

Identifier Source: org_study_id