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Assessment of Grazax® Treatment Compliance

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ClinicalTrials.gov Identifier: NCT00293046
Recruitment Status : Completed
First Posted : February 17, 2006
Last Update Posted : September 30, 2008
Sponsor:
Information provided by:

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

Condition or disease Intervention/treatment Phase
Allergy Biological: ALK Grass tablet - use of compliance device Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
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
Study Start Date : February 2006
Primary Completion Date : September 2006
Study Completion Date : October 2007
Arms and Interventions


Outcome Measures

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

Secondary Outcome Measures :
  1. Recording of adverse events

Eligibility Criteria

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 Posted: February 17, 2006    Key Record Dates
Last Update Posted: September 30, 2008
Last Verified: September 2008

Keywords provided by ALK-Abelló A/S:
Allergy