Study With Rupatadine in Mosquito-Bite Allergic Adult Subjects

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2005 by J. Uriach and Company.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
J. Uriach and Company
ClinicalTrials.gov Identifier:
NCT00258141
First received: November 23, 2005
Last updated: NA
Last verified: November 2005
History: No changes posted
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Prevention
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: 30
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
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, see Learn About Clinical Studies.

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

No publications provided

ClinicalTrials.gov Identifier: NCT00258141     History of Changes
Other Study ID Numbers: DM03RUP/IV/05
Study First Received: November 23, 2005
Last Updated: November 23, 2005
Health Authority: Finland: Finnish Medicines Agency

ClinicalTrials.gov processed this record on October 21, 2014