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Assessment of Grazax® Treatment Compliance

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00293046
First Posted: February 17, 2006
Last Update Posted: September 30, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
ALK-Abelló A/S
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00293046     History of Changes
Other Study ID Numbers: GT-10
First Submitted: February 16, 2006
First Posted: February 17, 2006
Last Update Posted: September 30, 2008
Last Verified: September 2008

Keywords provided by ALK-Abelló A/S:
Allergy