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
  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:


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
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: 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:
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 October 21, 2014