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
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: 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

ClinicalTrials.gov processed this record on October 23, 2014