Study With Rupatadine in Mosquito-Bite Allergic Adult Sub... | NCT00258141

Studies
Study With Rupatadine in Mosquito-Bite Allergic Adult Subjects

NCT00258141

Sponsor

J. Uriach and Company

Status

Unknown status

Last Update Posted

Nov 24, 2005Estimated

Enrollment

Phase

Phase 4

Conditions

Allergy

Interventions

Rupatadine
Placebo

Countries

Finland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2005

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Nov 23, 2005

First Submission Date that Met QC Criteria

Nov 23, 2005

First Posted Date

Nov 24, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 23, 2005

Last Update Posted Date

Nov 24, 2005Estimated

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Measure	Description	Time Frame
Bite lesion size (squared mm)

Measure	Description	Time Frame
Pruritus on a Visual Analog Scale

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Timo Reunala, Prof.	Contact	(+358) 331165167		timo.reunala@uta.fi

Overall Officials

Name	Affiliation	Role
Timo Reunala, Prof.	Medical School, University of Tampere and Tampere University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ulappatorin Lääkäriasema		Espoo			Finland

Name	Type	Description	Arm Group Labels	Other Names
Rupatadine	Drug
Placebo	Drug