Back to resultsEfficacy and Safety of a Purified Standardised Wasp Venom Preparation
Primary Purpose
Allergy
Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
wasp venom
Sponsored by
About this trial
This is an interventional treatment trial for Allergy focused on measuring Wasp venom allergy,, specific immunotherapy
Eligibility 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
Sites / Locations
- Allergopharma GmbH & Co. KG
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00263926
First Posted
December 9, 2005
Last Updated
March 8, 2013
Sponsor
Allergopharma GmbH & Co. KG
1. Study Identification
Unique Protocol Identification Number
NCT00263926
Brief Title
Efficacy and Safety of a Purified Standardised Wasp Venom Preparation
Official Title
Immunotherapy of Wasp Venom Allergy: Comparison of a Purified Preparation to Conventional Aqueous Wasp Venom in an Open Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
March 2001 (undefined)
Primary Completion Date
May 2007 (Actual)
Study Completion Date
November 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allergopharma GmbH & Co. KG
4. Oversight
5. Study Description
Brief Summary
The trial is performed to assess efficacy and safety of a purified standardised wasp venom preparation in wasp venom allergy
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergy
Keywords
Wasp venom allergy,, specific immunotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
wasp 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 wasp venom allergy,
Positive RAST to wasp venom,
Positive skin prick test to wasp 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 Wasp Venom Preparation
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