Safety and Efficacy of House Dust Mite Allergen Extract in the Treatment of Allergic Rhinoconjunctivitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergopharma GmbH & Co. KG
ClinicalTrials.gov Identifier:
NCT00263549
First received: December 8, 2005
Last updated: February 8, 2013
Last verified: February 2013
  Purpose

The trial is performed to assess efficacy and safety of Novo-Helisen Depot in allergic Rhinoconjunctivitis


Condition Intervention Phase
House Dust Mite Allergy
Biological: House dust mite Novo Helisen Depot
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Multicenter Study for Evaluation of Efficacy and Safety of Perennial Specific Immunotherapy With a Depot House Dust Mite Allergen Extract (D. Pteronyssinus 100%) in Patients With House Dust Mite Sensitivity

Resource links provided by NLM:


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

Study Start Date: September 2002
Study Completion Date: February 2006
Primary Completion Date: February 2005 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Positive skin prick test to house dust mite,
  • Positive RAST test to house dust mite,
  • Positive provocation test result to house dust mite,

Exclusion Criteria:

  • Serious chronic diseases,
  • Other perennial allergies
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00263549

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

Additional Information:
No publications provided

Responsible Party: Allergopharma GmbH & Co. KG
ClinicalTrials.gov Identifier: NCT00263549     History of Changes
Other Study ID Numbers: Al0201NH
Study First Received: December 8, 2005
Last Updated: February 8, 2013
Health Authority: Germany: Paul-Ehrlich-Institut

Keywords provided by Allergopharma GmbH & Co. KG:
House dust mite,
Allergy

Additional relevant MeSH terms:
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on April 16, 2014