This trial is performed to assess the efficacy and safety of the ALK Grass tablet for treatment of grass pollen induced rhinoconjunctivitis (hayfever).
Official Title
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
Conditions
- Allergy
Study Type
Interventional
Study Design
Treatment, Randomised, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study.
Further Details
- Recording of rhinoconjunctivitis symptoms
[Time Frame: After the grass pollen seasons 2007, 2008 and 2009]
[Designated as safety issue: No] - Recording of use of rescue medication
[Time Frame: After the grass pollen seasons 2007, 2008 and 2009]
[Designated as safety issue: No]
- Quality of life
[Time Frame: After the grass pollen seasons 2007, 2008 and 2009]
[Designated as safety issue: No]
Study Start
October 2004
Eligibility & Criteria
Eligibility Criteria:
- A history of grass pollen induced rhinoconjunctivitis
- Positive skin prick test to grass
- Positive specific IgE to grass
Total Enrolment
634
Contact Details
Please refer to this study by its ClinicalTrials.gov identifier: NCT00227279
Study Director:
Mette Ribel, MSc
ALK-Abello A/S
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