Back to resultsSafety and Efficacy of Recombinant Grass Pollen Allergen Cocktail in the Treatment of Allergic Rhinoconjunctivitis
Primary Purpose
Allergy
Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Recombinant grass pollen
Sponsored by
About this trial
This is an interventional treatment trial for Allergy focused on measuring Allergy, Grass pollen, Recombinant
Eligibility Criteria
Inclusion Criteria: Positive Skin Prick Test reaction to grass pollen Positive RAST result to grass pollen Positive Provocation Test result to grass pollen Exclusion Criteria: Serious chronic diseases Other relevant perennial allergies
Sites / Locations
- Allergopharma GmbH & Co. KG
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00309036
First Posted
March 30, 2006
Last Updated
March 8, 2013
Sponsor
Allergopharma GmbH & Co. KG
1. Study Identification
Unique Protocol Identification Number
NCT00309036
Brief Title
Safety and Efficacy of Recombinant Grass Pollen Allergen Cocktail in the Treatment of Allergic Rhinoconjunctivitis
Official Title
A Multicentre Randomised Placebo-controlled Double-blind Clinical Trial for Evaluation of Safety and Efficacy of Immunotherapy With an Aluminium Hydroxide-adsorbed Cocktail of Recombinant Derivatives of Major Allergens of Timothy Grass (Phleum Pratense).
Study Type
Interventional
2. Study Status
Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
January 2004 (undefined)
Primary Completion Date
September 2006 (Actual)
Study Completion Date
May 2008 (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 recombinant grass Pollen allergen cocktail in allergic rhinoconjunctivitis
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergy
Keywords
Allergy, Grass pollen, Recombinant
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
Recombinant grass pollen
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Positive Skin Prick Test reaction to grass pollen
Positive RAST result to grass pollen
Positive Provocation Test result to grass pollen
Exclusion Criteria:
Serious chronic diseases
Other relevant perennial allergies
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Annemie Narkus, MD
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
Safety and Efficacy of Recombinant Grass Pollen Allergen Cocktail in the Treatment of Allergic Rhinoconjunctivitis
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