Design of Optimally-diagnostic Skin Test Solutions for Di... | NCT00665483

Studies
Design of Optimally-diagnostic Skin Test Solutions for Diagnosis of Sensitisation to a Pollen and Dust Mite Mixture.

NCT00665483

Sponsor

Allergopharma GmbH & Co. KG

Status

Completed

Last Update Posted

Nov 8, 2013Estimated

Enrollment

Not provided

Phase

Phase 4

Conditions

Type I Allergy

Interventions

Skin Prick Test

Countries

Germany

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

ID	Type	Description	Link
2006-005304-14	EudraCT Number

Status Module

Record Verification Date

Nov 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2007

Primary Completion Date

Sep 2007Actual

Completion Date

Nov 2010Actual

First Submitted Date

Apr 22, 2008

First Submission Date that Met QC Criteria

Apr 23, 2008

First Posted Date

Apr 24, 2008Estimated

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 7, 2013

Last Update Posted Date

Nov 8, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

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

No data available

No data is available for this block.

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Skin Prick Test	Other: Skin Prick Test

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Skin Prick Test	Other	Skin Prick Test	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Optimal trade-off between sensitivity and specificity		December 2007 - December 2008

Secondary Outcomes

Measure	Description	Time Frame
Evaluation of the documentation of adverse events		January - December 2008

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

anamnesis referring to suspicion of an IgE-mediated allergy
positive Skin Prick Test in the medical history to at least one of the investigational allergens with an existing anamnesis

Exclusion Criteria:

serious chronic diseases
Other perennial allergies

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Nicola Wagner, MD	Klinikum Darmstadt	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Klinikum Darmstadt		Darmstadt	Hesse	64297	Germany

References Module

Citations

Not provided

Label	URL
Leader in specific allergy research and therapy	View source
Click here for information about this trial in the European Clinical Trials Register	View source

ID	Term
D012882	Skin Tests
D007159	Immunologic Tests
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures