Study With Rupatadine in Mosquito-Bite Allergic Adult Subjects

November 23, 2005 updated by: J. Uriach and Company

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

30

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Finland
      • Espoo, Finland
        • Ulappatorin Lääkäriasema
        • Principal Investigator:
          • Leena Ackermann, MD
      • Tampere, Finland, 33101
        • Koskiklinikka, Tampere Lääkärikeskus
        • Principal Investigator:
          • Ari Karppinen, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Bite lesion size (squared mm)

Secondary Outcome Measures

Outcome Measure
Pruritus on a Visual Analog Scale

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

J. Uriach and Company

Investigators

  • Principal Investigator: Timo Reunala, Prof., Medical School, University of Tampere and Tampere University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

November 23, 2005

First Submitted That Met QC Criteria

November 23, 2005

First Posted (Estimate)

November 24, 2005

Study Record Updates

Last Update Posted (Estimate)

November 24, 2005

Last Update Submitted That Met QC Criteria

November 23, 2005

Last Verified

November 1, 2005

More Information

Terms related to this study

Other Study ID Numbers

  • DM03RUP/IV/05

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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