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Study With Rupatadine in Mosquito-Bite Allergic Adult Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00258141
Recruitment Status : Unknown
Verified November 2005 by J. Uriach and Company.
Recruitment status was:  Not yet recruiting
First Posted : November 24, 2005
Last Update Posted : November 24, 2005
Information provided by:
J. Uriach and Company

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.

Condition or disease Intervention/treatment Phase
Allergy Drug: Rupatadine Drug: Placebo Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: A Placebo-Controlled, Double-Blind, Cross-Over Study With Rupatadine 10 Mg in 30 Mosquito-Bite Allergic Adult Subjects

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mosquito Bites

Primary Outcome Measures :
  1. Bite lesion size (squared mm)

Secondary Outcome Measures :
  1. Pruritus on a Visual Analog Scale

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00258141

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Contact: Timo Reunala, Prof. (+358) 331165167

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Ulappatorin Lääkäriasema
Espoo, Finland
Principal Investigator: Leena Ackermann, MD         
Koskiklinikka, Tampere Lääkärikeskus
Tampere, Finland, 33101
Principal Investigator: Ari Karppinen, MD         
Sponsors and Collaborators
J. Uriach and Company
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Principal Investigator: Timo Reunala, Prof. Medical School, University of Tampere and Tampere University Hospital

Layout table for additonal information Identifier: NCT00258141    
Other Study ID Numbers: DM03RUP/IV/05
First Posted: November 24, 2005    Key Record Dates
Last Update Posted: November 24, 2005
Last Verified: November 2005
Additional relevant MeSH terms:
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Dermatologic Agents
Gastrointestinal Agents
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Serotonin Antagonists
Serotonin Agents
Anti-Allergic Agents