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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Allergopharma GmbH & Co. KG

ClinicalTrials.gov Identifier:

NCT00665483

First received: April 22, 2008

Last updated: March 8, 2013

Last verified: March 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

April 22, 2008

Last Updated Date

March 8, 2013

Start Date ^ICMJE

March 2007

Primary Completion Date

September 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Optimal trade-off between sensitivity and specificity [ Time Frame: December 2007 - December 2008 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Optimal trade-off between sensitivity and specificity done by the method of Receiver Operating Characteristic [ Time Frame: December 2007 - December 2008 ] [ Designated as safety issue: No ]

Change History

Complete list of historical versions of study NCT00665483 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Evaluation of the documentation of adverse events [ Time Frame: January - December 2008 ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Design of Optimally-diagnostic Skin Test Solutions for Diagnosis of Sensitisation to a 6-grass Pollen Mixture, House Dust Mite (Dermatophagoides Pteronyssinus), Birch Pollen, and Mugwort Pollen

Brief Summary

Multicenter Skin Prick Test

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Not Provided

Condition ^ICMJE

Type I Allergy

Intervention ^ICMJE

Other: Skin Prick Test

Skin Prick Test

Study Arm (s)

Experimental: 1

Skin Prick Test

Intervention: Other: Skin Prick Test

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Not Provided

Completion Date

November 2010

Primary Completion Date

September 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 60 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Germany

Administrative Information

NCT Number ^ICMJE

NCT00665483

Other Study ID Numbers ^ICMJE

AL0205PR, 2006-005304-14

Has Data Monitoring Committee

Responsible Party

Allergopharma GmbH & Co. KG

Study Sponsor ^ICMJE

Allergopharma GmbH & Co. KG

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Nicola Wagner, MD

Klinikum Darmstadt

Information Provided By

Allergopharma GmbH & Co. KG

Verification Date

March 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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