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
  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:


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
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: 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 August 20, 2014