Back to resultsEfficacy and Safety of a Purified Standardised Bee Venom Preparation
Primary Purpose
Bee Venom Allergy
Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
bee venom
Sponsored by
About this trial
This is an interventional treatment trial for Bee Venom Allergy focused on measuring Bee venom allergy, Specific immunotherapy
Eligibility 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
Sites / Locations
- Allergopharma GmbH & Co. KG
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00263952
First Posted
December 9, 2005
Last Updated
March 1, 2013
Sponsor
Allergopharma GmbH & Co. KG
1. Study Identification
Unique Protocol Identification Number
NCT00263952
Brief Title
Efficacy and Safety of a Purified Standardised Bee Venom Preparation
Official Title
Immunotherapy of Bee Venom Allergy: Evaluation of a New Purified Bee Venom Preparation in Comparison With Already Published Studies.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
March 2003 (undefined)
Primary Completion Date
January 2005 (Actual)
Study Completion Date
April 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allergopharma GmbH & Co. KG
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The trial is performed to assess efficacy and safety of a purified standardised bee venom preparation in bee venom allergy
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bee Venom Allergy
Keywords
Bee venom allergy, Specific immunotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
bee venom
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Annemie Narkus, M.D.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Allergopharma GmbH & Co. KG
City
Reinbek
ZIP/Postal Code
21465
Country
Germany
12. IPD Sharing Statement
Links:
URL
http://www.allergopharma.de
Description
Leader in specific allergy research and therapy
Learn more about this trial
Efficacy and Safety of a Purified Standardised Bee Venom Preparation
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