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Efficacy and Safety of a Purified Standardised Wasp Venom Preparation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergopharma GmbH & Co. KG
ClinicalTrials.gov Identifier:
NCT00263926
First received: December 9, 2005
Last updated: March 8, 2013
Last verified: March 2013
History of Changes
  Purpose

The trial is performed to assess efficacy and safety of a purified standardised wasp venom preparation in wasp venom allergy


Condition Intervention Phase
Allergy
 Biological: wasp venom
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Immunotherapy of Wasp Venom Allergy: Comparison of a Purified Preparation to Conventional Aqueous Wasp Venom in an Open Controlled Study

Resource links provided by NLM:

MedlinePlus related topics: Allergy
U.S. FDA Resources

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

Study Start Date: March 2001
Study Completion Date: November 2010
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • History of wasp venom allergy,
  • Positive RAST to wasp venom,
  • Positive skin prick test to wasp venom

Exclusion Criteria:

  • Serious chronic diseases
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00263926

Locations
Germany
Allergopharma GmbH & Co. KG
Reinbek, Germany, 21465
Sponsors and Collaborators
Allergopharma GmbH & Co. KG
Investigators
Principal Investigator: Annemie Narkus, M.D.
  More Information

Additional Information:
Leader in specific allergy research and therapy  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Allergopharma GmbH & Co. KG
ClinicalTrials.gov Identifier: NCT00263926     History of Changes
Other Study ID Numbers: Al1000ig
Study First Received: December 9, 2005
Last Updated: March 8, 2013
Health Authority: Germany: Paul-Ehrlich-Institut

Keywords provided by Allergopharma GmbH & Co. KG:
Wasp venom allergy,
specific immunotherapy

Additional relevant MeSH terms:
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on May 22, 2013