The ALK Grass Tablet in Subjects with Hayfever

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 Randomised, 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
• Recording of use of rescue medication

Secondary Outcome Measures:

• Quality of life

Study Start

October 2004

Eligibility & Criteria

Eligibility:

• Ages Eligible for Study: 18 Years to 65 Years
• Genders Eligible for Study: Both
• Accepts Healthy Volunteers: No

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

Sponsors and Collaborators: ALK-Abelló A/S

Investigators: Mette Ribel, MSc ALK-Abello A/S