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Assessment of Grazax® Treatment Compliance
This study has been completed.
Sponsored by: ALK-Abelló A/S
Information provided by: ALK-Abelló A/S
ClinicalTrials.gov Identifier: NCT00293046
  Purpose

This trial is performed to assess whether the Grazax® treatment compliance can be improved by use of a compliance device (Memozax®).


Condition Intervention Phase
Allergy
Biological: ALK Grass tablet - use of compliance device
Phase III

MedlinePlus related topics: Allergy
U.S. FDA Resources
Study Type: Interventional
Study Design: Randomized, Open Label, Active Control, Parallel Assignment
Official Title: A Randomised, Parallel-Group, Open, Controlled Phase III Trial Assessing the Treatment Compliance With GRAZAX® in Subjects With Seasonal Grass Pollen Induced Rhinoconjunctivitis

Further study details as provided by ALK-Abelló A/S:

Primary Outcome Measures:
  • Assessment of treatment compliance by recording of drug accountability

Secondary Outcome Measures:
  • Recording of adverse events

Estimated Enrollment: 500
Study Start Date: February 2006
Study Completion Date: October 2007
Primary Completion Date: September 2006 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Grass pollen induced rhinoconjunctivitis
  • Males and females, 18-65 years of age
  • Positive skin prick test

Exclusion Criteria:

  • Previous treatment with grass pollen allergen
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00293046

Locations
Austria
Allgergie - Ambulatorium Rennweg
Wien, Austria, 1030
Sponsors and Collaborators
ALK-Abelló A/S
Investigators
Study Director: Kim Simonsen, MD ALK-Abelló A/S
  More Information

Study ID Numbers: GT-10
Study First Received: February 16, 2006
Last Updated: September 29, 2008
ClinicalTrials.gov Identifier: NCT00293046  
Health Authority: Denmark: Danish Medicines Agency;   Austria: Federal Ministry for Health and Women;   Sweden: Medical Products Agency;   Netherlands: Medicines Evaluation Board (MEB);   Germany: Paul-Ehrlich-Institut

Keywords provided by ALK-Abelló A/S:
Allergy

Study placed in the following topic categories:
Hypersensitivity

ClinicalTrials.gov processed this record on January 14, 2009