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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: November 7, 2013
Last verified: November 2013
  Purpose

Multicenter Skin Prick Test


Condition Intervention Phase
Type I Allergy
Other: Skin Prick Test
Phase 4

Study Type: Interventional
Official Title: 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

Further study details as provided by Allergopharma GmbH & Co. KG:

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

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

Study Start Date: March 2007
Study Completion Date: November 2010
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Skin Prick Test
Other: Skin Prick Test
Skin Prick Test

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00665483

Locations
Germany
Klinikum Darmstadt
Darmstadt, Hessen, Germany, 64297
Sponsors and Collaborators
Allergopharma GmbH & Co. KG
Investigators
Principal Investigator: Nicola Wagner, MD Klinikum Darmstadt
  More Information

Additional Information:
No publications provided

Responsible Party: Allergopharma GmbH & Co. KG
ClinicalTrials.gov Identifier: NCT00665483     History of Changes
Other Study ID Numbers: AL0205PR, 2006-005304-14
Study First Received: April 22, 2008
Last Updated: November 7, 2013
Health Authority: Germany: Paul-Ehrlich-Institut

ClinicalTrials.gov processed this record on November 27, 2014