Efficacy and Safety of a Purified Standardised Bee Venom Preparation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergopharma GmbH & Co. KG
ClinicalTrials.gov Identifier:
NCT00263952
First received: December 9, 2005
Last updated: March 1, 2013
Last verified: March 2013
  Purpose

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


Condition Intervention Phase
Bee Venom Allergy
Biological: bee venom
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Immunotherapy of Bee Venom Allergy: Evaluation of a New Purified Bee Venom Preparation in Comparison With Already Published Studies.

Resource links provided by NLM:


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

Study Start Date: March 2003
Study Completion Date: April 2010
Primary Completion Date: January 2005 (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 bee venom allergy,
  • Positive RAST for bee venom,
  • Positive skin prick test for bee venom

Exclusion Criteria:

  • Serious chronic diseases
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00263952

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: NCT00263952     History of Changes
Other Study ID Numbers: Al0202ig
Study First Received: December 9, 2005
Last Updated: March 1, 2013
Health Authority: Germany: Paul-Ehrlich-Institut

Keywords provided by Allergopharma GmbH & Co. KG:
Bee venom allergy
Specific immunotherapy

Additional relevant MeSH terms:
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on April 22, 2014