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NCT00293046 Clinical Trial

Assessment of Grazax® Treatment Compliance

Allergy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00293046
Other study ID # GT-10
Secondary ID
Status Completed
Phase Phase 3
First received February 16, 2006
Last updated September 29, 2008
Start date February 2006
Est. completion date October 2007

Study information
Verified date September 2008
Source ALK-Abelló A/S
Contact n/a
Is FDA regulated No
Health authority Denmark: Danish Medicines AgencyAustria: Federal Ministry for Health and WomenSweden: Medical Products AgencyNetherlands: Medicines Evaluation Board (MEB)Germany: Paul-Ehrlich-Institut
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 500
Est. completion date October 2007
Est. primary completion date September 2006
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility 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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

Intervention

Biological:
• ALK Grass tablet - use of compliance device

Locations
Country Name City State
Austria Allgergie - Ambulatorium Rennweg Wien

Sponsors (1)
Lead Sponsor Collaborator
ALK-Abelló A/S

Country where clinical trial is conducted

Austria, 

Outcome
Type Measure Description Time frame Safety issue
Primary Assessment of treatment compliance by recording of drug accountability
Secondary Recording of adverse events
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