Safety and Efficacy of Recombinant Grass Pollen Allergen Cocktail in the Treatment of Allergic Rhinoconjunctivitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergopharma GmbH & Co. KG
ClinicalTrials.gov Identifier:
NCT00309036
First received: March 30, 2006
Last updated: March 8, 2013
Last verified: March 2013
  Purpose

The trial is performed to assess efficacy and safety of a recombinant grass Pollen allergen cocktail in allergic rhinoconjunctivitis


Condition Intervention Phase
Allergy
Biological: Recombinant grass pollen
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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).

Resource links provided by NLM:


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

Study Start Date: January 2004
Study Completion Date: May 2008
Primary Completion Date: September 2006 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00309036

Locations
Germany
Allergopharma GmbH & Co. KG
Reinbek, Germany, 21465
Sponsors and Collaborators
Allergopharma GmbH & Co. KG
Investigators
Principal Investigator: Annemie Narkus, MD
  More Information

Additional Information:
No publications provided

Responsible Party: Allergopharma GmbH & Co. KG
ClinicalTrials.gov Identifier: NCT00309036     History of Changes
Other Study ID Numbers: Al0403rP
Study First Received: March 30, 2006
Last Updated: March 8, 2013
Health Authority: Germany: Paul-Ehrlich-Institut

Keywords provided by Allergopharma GmbH & Co. KG:
Allergy
Grass pollen
Recombinant

ClinicalTrials.gov processed this record on September 30, 2014