- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00309036
Safety and Efficacy of Recombinant Grass Pollen Allergen Cocktail in the Treatment of Allergic Rhinoconjunctivitis
March 8, 2013 updated by: Allergopharma GmbH & Co. KG
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).
The trial is performed to assess efficacy and safety of a recombinant grass Pollen allergen cocktail in allergic rhinoconjunctivitis
Study Overview
Study Type
Interventional
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Reinbek, Germany, 21465
- Allergopharma GmbH & Co. KG
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Annemie Narkus, MD
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2004
Primary Completion (Actual)
September 1, 2006
Study Completion (Actual)
May 1, 2008
Study Registration Dates
First Submitted
March 30, 2006
First Submitted That Met QC Criteria
March 30, 2006
First Posted (Estimate)
March 31, 2006
Study Record Updates
Last Update Posted (Estimate)
March 11, 2013
Last Update Submitted That Met QC Criteria
March 8, 2013
Last Verified
March 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Al0403rP
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Allergy
-
University of RochesterNational Institute of Allergy and Infectious Diseases (NIAID)Not yet recruitingEgg Allergy | Food Allergy Peanut | Food Allergy in Infants | Allergy and Immunology | Peanut and Nut AllergyUnited States
-
Hong Kong Sanatorium & HospitalChinese University of Hong KongTerminatedAllergy to Fish | Allergy to Shrimp | Allergy to CrabHong Kong
-
King's College LondonGuy's and St Thomas' NHS Foundation TrustUnknownEgg Allergy | Food Allergy | Food Allergy in Children | Milk Allergy | Food Allergy in Infants | Nut Allergy | Food Allergen SensitisationUnited Kingdom
-
Abionic SAJohns Hopkins University; NAMSAWithdrawnAllergy | Allergic Asthma | Allergy to Cats | Allergy to House Dust | Allergy Cockroach | Allergy to Dog Dander (Finding) | Allergy MoldUnited States
-
Peking University Third HospitalCancer Institute and Hospital, Chinese Academy of Medical Sciences; Beijing... and other collaboratorsRecruitingCow Milk Allergy | Food Allergy in ChildrenChina
-
King's College LondonKing's College Hospital NHS Trust; University College London Hospitals; Cambridge... and other collaboratorsRecruitingEgg Allergy | Food Allergy | Food Allergy in Children | Milk Allergy | Food Allergy in Infants | Nut Allergy | Food Allergen SensitisationUnited Kingdom
-
Chinese University of Hong KongRecruiting
-
Martini Hospital GroningenRecruitingCow Milk Allergy | Food AllergyNetherlands
-
University GhentActive, not recruitingCow Milk Allergy | Food AllergyBelgium
-
Sayantani B. SindherNational Institute of Allergy and Infectious Diseases (NIAID)TerminatedAllergy;Food | Allergy to Shrimp | Allergy to Cashew Nut (Disorder)United States
Clinical Trials on Recombinant grass pollen
-
AlyatecCompletedAllergic Rhinitis Due to Grass PollenFrance
-
University Hospital, Strasbourg, FranceCompleted
-
Fraunhofer-Institute of Toxicology and Experimental...CompletedAsthma | Seasonal Allergic RhinitisGermany
-
Artu BiologicalsCompletedAllergic RhinoconjunctivitisBulgaria, Lithuania, Czech Republic, Germany, Hungary, Netherlands, Slovakia
-
Artu BiologicalsUnknownAllergic RhinoconjunctivitisNetherlands, United Kingdom, Germany, Poland, Belgium, France
-
Fraunhofer-Institute of Toxicology and Experimental...CompletedHealthy Subjects | Seasonal Allergic RhinitisGermany
-
Johann Wolfgang Goethe University HospitalCompletedHypersensitivity | Allergy | Bronchial Hyperreactivity | Bronchial AsthmaGermany
-
Allergy TherapeuticsCompletedType I HypersensitivityGermany
-
Amber PattersonNationwide Children's HospitalUnknown
-
Johann Wolfgang Goethe University HospitalCompleted