Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
253 participants
INTERVENTIONAL
2006-11-30
2007-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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1
Grazax treatment
Grazax-R
Grass tablet, 75.000 SQ per day for one year
2
Grazax Placebo
Grazax Placebo
Grazax Placebo, 0 SQ tablet per day for one year
Interventions
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Grazax-R
Grass tablet, 75.000 SQ per day for one year
Grazax Placebo
Grazax Placebo, 0 SQ tablet per day for one year
Eligibility Criteria
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Inclusion Criteria
* A clinical history of grass pollen induced hayfever
* Positive Skin Prick Test to Phleum pratense
* Positive specific IgE against Phleum pratense
Exclusion Criteria
* History of perennial hayfever (and/or asthma) that needs medication due to an allergen to which the child is regularly exposed
* History of severe asthma
* Current severe atopic dermatitis
5 Years
16 Years
ALL
No
Sponsors
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ALK-Abelló A/S
INDUSTRY
Principal Investigators
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Friedrich Kaiser, Dr. med.
Role: PRINCIPAL_INVESTIGATOR
Tangstedter Landstrasse 77, 22415 Hamburg, Germany
Locations
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Tangstedter Landstrasse 77
Hamburg, , Germany
Countries
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References
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Bufe A, Eberle P, Franke-Beckmann E, Funck J, Kimmig M, Klimek L, Knecht R, Stephan V, Tholstrup B, Weisshaar C, Kaiser F. Safety and efficacy in children of an SQ-standardized grass allergen tablet for sublingual immunotherapy. J Allergy Clin Immunol. 2009 Jan;123(1):167-173.e7. doi: 10.1016/j.jaci.2008.10.044.
Other Identifiers
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GT-12
Identifier Type: -
Identifier Source: org_study_id
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