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Study With Rupatadine in Mosquito-Bite Allergic Adult Subjects

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ClinicalTrials.gov 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
Sponsor:
Information provided by:

Study Description
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.


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated 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
U.S. FDA Resources

Arms and Interventions


Outcome Measures

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

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

Eligibility Criteria

Information from the National Library of Medicine

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

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 ClinicalTrials.gov identifier (NCT number): NCT00258141


Contacts
Contact: Timo Reunala, Prof. (+358) 331165167 timo.reunala@uta.fi

Locations
Finland
Ulappatorin Lääkäriasema Not yet recruiting
Espoo, Finland
Principal Investigator: Leena Ackermann, MD         
Koskiklinikka, Tampere Lääkärikeskus Not yet recruiting
Tampere, Finland, 33101
Principal Investigator: Ari Karppinen, MD         
Sponsors and Collaborators
J. Uriach and Company
Investigators
Principal Investigator: Timo Reunala, Prof. Medical School, University of Tampere and Tampere University Hospital
More Information

ClinicalTrials.gov Identifier: NCT00258141     History of Changes
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:
Cyproheptadine
Antipruritics
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