Study With Rupatadine in Mosquito-Bite Allergic Adult Subjects

This study is not yet open for participant recruitment.

Verified by J. Uriach and Company, November 2005

Sponsored by:	J. Uriach and Company
Information provided by:	J. Uriach and Company
ClinicalTrials.gov Identifier:	NCT00258141

Purpose

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

Condition	Intervention	Phase
Allergy	Drug: Rupatadine Drug: Placebo	Phase IV

MedlinePlus related topics: Animal Bites

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study
Official Title:	A Placebo-Controlled, Double-Blind, Cross-Over Study With Rupatadine 10 Mg in 30 Mosquito-Bite Allergic Adult Subjects

Further study details as provided by J. Uriach and Company:

Primary Outcome Measures:

Bite lesion size (squared mm)

Secondary Outcome Measures:

Pruritus on a Visual Analog Scale

Estimated Enrollment:

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.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00258141

Contacts

Contact: Timo Reunala, Prof.

(+358) 331165167

timo.reunala@uta.fi

Locations

Finland
Koskiklinikka, Tampere Lääkärikeskus
Tampere, Finland, 33101
Ulappatorin Lääkäriasema
Espoo, Finland

Sponsors and Collaborators

J. Uriach and Company

Investigators

Principal Investigator:

Timo Reunala, Prof.

Medical School, University of Tampere and Tampere University Hospital

More Information

Study ID Numbers:	DM03RUP/IV/05
Study First Received:	November 23, 2005
Last Updated:	November 23, 2005
ClinicalTrials.gov Identifier:	NCT00258141
Health Authority:	Finland: National Agency for Medicines

Study placed in the following topic categories:

Hypersensitivity
Bites and Stings

ClinicalTrials.gov processed this record on January 14, 2009