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

Primary Outcome Measures:

  • 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]

Secondary Outcome Measures:

  • 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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