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Assessment of Grazax® Treatment Compliance

This study has been completed.
Sponsor:
Information provided by:
ALK-Abelló A/S
ClinicalTrials.gov Identifier:
NCT00293046
First received: February 16, 2006
Last updated: September 29, 2008
Last verified: September 2008
History of Changes
  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: 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

Resource links provided by NLM:

MedlinePlus related topics: Allergy
U.S. FDA Resources

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

No publications provided

ClinicalTrials.gov Identifier: NCT00293046     History of Changes
Other Study ID Numbers: GT-10
Study First Received: February 16, 2006
Last Updated: September 29, 2008
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

Additional relevant MeSH terms:
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on May 22, 2013