A Trial of Grazax in Subjects With Hayfever

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00421655
Recruitment Status : Completed
First Posted : January 12, 2007
Last Update Posted : June 24, 2015
Information provided by:
ALK-Abelló A/S

January 11, 2007
January 12, 2007
June 24, 2015
December 2006
August 2007   (Final data collection date for primary outcome measure)
Recording of allergy symptoms [ Time Frame: Grass pollen season 2007 ]
Recording of allergy symptoms
Complete list of historical versions of study NCT00421655 on Archive Site
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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.
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Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Drug: Grazax
Tablets 75,000 SQT and matching placebo. One tablet daily.
  • Experimental: 1
    Intervention: Drug: Grazax
  • Placebo Comparator: 2
    Intervention: Drug: Grazax
Murphy K, Gawchik S, Bernstein D, Andersen J, Pedersen MR. A phase 3 trial assessing the efficacy and safety of grass allergy immunotherapy tablet in subjects with grass pollen-induced allergic rhinitis with or without conjunctivitis, with or without asthma. J Negat Results Biomed. 2013 Jun 1;12:10. doi: 10.1186/1477-5751-12-10.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
United States
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Kim Simonsen, MD, Senior Director, ALK-Abello
ALK-Abelló A/S
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Study Director: Kim Simonsen, MD ALK-Abelló A/S
ALK-Abelló A/S
June 2015

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