NCT00258141

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for phase_4

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 23, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 24, 2005

Completed
Last Updated

November 24, 2005

Status Verified

November 1, 2005

First QC Date

November 23, 2005

Last Update Submit

November 23, 2005

Conditions

Allergy

Outcome Measures

Primary Outcomes (1)

  • Bite lesion size (squared mm)

Secondary Outcomes (1)

  • Pruritus on a Visual Analog Scale

Interventions

RupatadineDRUG
PlaceboDRUG

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Recent history of suffering from mosquito-bite reactions.
  • At least 5 mm diameter mosquito-bite wheal from Aedes aegypti laboratory mosquitoes

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ulappatorin Lääkäriasema

Espoo, Finland

Location

Koskiklinikka, Tampere Lääkärikeskus

Tampere, 33101, Finland

Location

MeSH Terms

Conditions

Hypersensitivity

Interventions

rupatadine

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Officials

  • Timo Reunala, Prof.

    Medical School, University of Tampere and Tampere University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Timo Reunala, Prof.

CONTACT

(+358) 331165167timo.reunala@uta.fi

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 23, 2005

First Posted

November 24, 2005

Last Updated

November 24, 2005

Record last verified: 2005-11

Locations

FI(2)