- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00293046
Assessment of Grazax® Treatment Compliance
September 29, 2008 updated by: ALK-Abelló A/S
A Randomised, Parallel-Group, Open, Controlled Phase III Trial Assessing the Treatment Compliance With GRAZAX® in Subjects With Seasonal Grass Pollen Induced Rhinoconjunctivitis
This trial is performed to assess whether the Grazax® treatment compliance can be improved by use of a compliance device (Memozax®).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment
500
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Wien, Austria, 1030
- Allgergie - Ambulatorium Rennweg
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Assessment of treatment compliance by recording of drug accountability
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Secondary Outcome Measures
Outcome Measure |
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Recording of adverse events
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2006
Primary Completion (Actual)
September 1, 2006
Study Completion (Actual)
October 1, 2007
Study Registration Dates
First Submitted
February 16, 2006
First Submitted That Met QC Criteria
February 16, 2006
First Posted (Estimate)
February 17, 2006
Study Record Updates
Last Update Posted (Estimate)
September 30, 2008
Last Update Submitted That Met QC Criteria
September 29, 2008
Last Verified
September 1, 2008
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- GT-10
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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