A Trial of Grazax in Subjects With Hayfever

This study has been completed.
Sponsor:
Information provided by:
ALK-Abelló A/S
ClinicalTrials.gov Identifier:
NCT00421655
First received: January 11, 2007
Last updated: February 28, 2008
Last verified: February 2008

January 11, 2007
February 28, 2008
December 2006
August 2007   (final data collection date for primary outcome measure)
Recording of allergy symptoms [ Time Frame: Grass pollen season 2007 ] [ Designated as safety issue: Yes ]
Recording of allergy symptoms
Complete list of historical versions of study NCT00421655 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
A Trial of Grazax in Subjects With Hayfever
A Phase III Trial Assessing the Efficacy and Safety of Grazax in Subjects With Seasonal Grass Pollen Induced Rhinoconjunctivitis With or Without Asthma

The trial is performed to evaluate the efficacy and safety of specific immunotherapy with Grazax for treatment of grass pollen induced allergy.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Allergy
Drug: Grazax
Tablets 75,000 SQT and matching placebo. One tablet daily.
  • Experimental: 1
    Intervention: Drug: Grazax
  • Placebo Comparator: 2
    Intervention: Drug: Grazax
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
329
October 2007
August 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • History of grass pollen allergy
  • Positive skin prick test to grass
  • Positive specific IgE to grass

Exclusion Criteria

  • FEV1 <70% of predicted value
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00421655
GT-14
Yes
Kim Simonsen, MD, Senior Director, ALK-Abello
ALK-Abelló A/S
Not Provided
Study Director: Kim Simonsen, MD ALK-Abelló A/S
ALK-Abelló A/S
February 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP