Not Signed In -
Allergy |
Allergies; Allergy/Allergies; Anaphylaxis |
Clinical Trial: Study With Rupatadine in Mosquito-Bite Allergic Adult Subjects
This study is not yet open for patient recruitment.
Verified by J. Uriach and Company November 2005
|
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: Allergy
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 Outcomes: Bite lesion size (squared mm)
Secondary Outcomes: Pruritus on a Visual Analog Scale
Expected Total Enrollment: 30
Secondary Outcomes: Pruritus on a Visual Analog Scale
Expected Total Enrollment: 30
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 - 65 Years, Genders Eligible for Study: Both
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
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00258141
Timo Reunala, Prof. (+358) 331165167 timo.reunala@uta.fi
Finland
Koskiklinikka, Tampere Lääkärikeskus, Tampere, 33101, Finland
Ari Karppinen, MD, Principal Investigator
Ulappatorin Lääkäriasema, Espoo, Finland
Leena Ackermann, MD, Principal Investigator
Study chairs or principal investigators
Timo Reunala, Prof., Principal Investigator, Medical School, University of Tampere and Tampere University Hospital
More Information
Study ID Numbers: DM03RUP/IV/05
Last Updated: December 8, 2005
Record first received: November 23, 2005
ClinicalTrials.gov Identifier: NCT00258141
Health Authority: Finland: National Agency for Medicines
ClinicalTrials.gov processed this record on 2006-01-10
Last Updated: December 8, 2005
Record first received: November 23, 2005
ClinicalTrials.gov Identifier: NCT00258141
Health Authority: Finland: National Agency for Medicines
ClinicalTrials.gov processed this record on 2006-01-10
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