Allergy Clinical Trial
Official title:
A Placebo-Controlled, Double-Blind, Cross-Over Study With Rupatadine 10 Mg in 30 Mosquito-Bite Allergic Adult Subjects
NCT number | NCT00258141 |
Other study ID # | DM03RUP/IV/05 |
Secondary ID | |
Status | Not yet recruiting |
Phase | Phase 4 |
First received | November 23, 2005 |
Last updated | November 23, 2005 |
The study will find out how effective rupatadine is in the treatment of mosquito bite symptoms in adult patients allergic to mosquito bites.
Status | Not yet recruiting |
Enrollment | 30 |
Est. completion date | |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Finland | Ulappatorin Lääkäriasema | Espoo | |
Finland | Koskiklinikka, Tampere Lääkärikeskus | Tampere |
Lead Sponsor | Collaborator |
---|---|
J. Uriach and Company |
Finland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Bite lesion size (squared mm) | |||
Secondary | Pruritus on a Visual Analog Scale |
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---|---|---|---|
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