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A Trial of the ALK Grass Tablet in Subjects With Hayfever

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00227279
First Posted: September 28, 2005
Last Update Posted: January 29, 2013
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.
Information provided by (Responsible Party):
ALK-Abelló A/S
September 26, 2005
September 28, 2005
January 29, 2013
October 2004
September 2009   (Final data collection date for primary outcome measure)
  • Recording of rhinoconjunctivitis symptoms [ Time Frame: Daily recordings during the entire grass pollen seasons 2007, 2008 and 2009 ]
  • Recording of use of rescue medication [ Time Frame: Daily recordings during the entire grass pollen seasons 2007, 2008 and 2009 ]
  • Recording of rhinoconjunctivitis symptoms
  • Recording of use of rescue medication
Complete list of historical versions of study NCT00227279 on ClinicalTrials.gov Archive Site
Quality of life [ Time Frame: Weekly recordings during the entire grass pollen seasons 2007, 2008 and 2009 ]
Quality of life
Not Provided
Not Provided
 
A Trial of the ALK Grass Tablet in Subjects With Hayfever
A Randomized, Parallel-group, Double-blind, Placebo-controlled Phase III Trial Assessing the Efficacy and Safety of ALK Grass Tablet in Subjects With Seasonal Grass Pollen Induced Rhinoconjunctivitis
This trial is performed to assess the efficacy and safety of the ALK Grass tablet for treatment of grass pollen induced rhinoconjunctivitis (hayfever).
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Allergy
Biological: ALK Grass tablet
Tablets, 75,000 SQ-T or matching placebo. Daily administration for 3 years
  • Experimental: 1
    Intervention: Biological: ALK Grass tablet
  • Placebo Comparator: 2
    Intervention: Biological: ALK Grass tablet

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
634
September 2009
September 2009   (Final data collection date for primary outcome measure)

Eligibility Criteria:

  • A history of grass pollen induced rhinoconjunctivitis
  • Positive skin prick test to grass
  • Positive specific IgE to grass
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
 
NCT00227279
GT-08
Not Provided
Not Provided
Not Provided
ALK-Abelló A/S
ALK-Abelló A/S
Not Provided
Study Director: Bente Tholstrup, MSc ALK-Abello A/S
ALK-Abelló A/S
January 2013

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