A Trial of the ALK Grass Tablet in Subjects With Hayfever - Full Text View

Sponsored by:	ALK-Abelló A/S
Information provided by:	ALK-Abelló A/S
ClinicalTrials.gov Identifier:	NCT00227279

Purpose

This trial is performed to assess the efficacy and safety of the ALK Grass tablet for treatment of grass pollen induced rhinoconjunctivitis (hayfever).

Condition	Intervention	Phase
Allergy	Biological: ALK Grass tablet	Phase III

MedlinePlus related topics: Allergy Hay Fever

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by ALK-Abelló A/S:

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 ]

Enrollment:	634
Study Start Date:	October 2004
Estimated Study Completion Date:	September 2009
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Biological: ALK Grass tablet Tablets, 75,000 SQ-T or matching placebo. Daily administration for 3 years
2: Placebo Comparator	Biological: ALK Grass tablet Tablets, 75,000 SQ-T or matching placebo. Daily administration for 3 years

Eligibility

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

Criteria

Eligibility Criteria:

A history of grass pollen induced rhinoconjunctivitis
Positive skin prick test to grass
Positive specific IgE to grass

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00227279

Sponsors and Collaborators

ALK-Abelló A/S

Investigators

Study Director:

Mette Ribel, MSc

ALK-Abello A/S

More Information

Responsible Party:	ALK-Abello ( Kim Simonsen, Senior Director )
Study ID Numbers:	GT-08
Study First Received:	September 26, 2005
Last Updated:	March 5, 2008
ClinicalTrials.gov Identifier:	NCT00227279
Health Authority:	Denmark: Danish Medicines Agency; Sweden: Medical Products Agency; Germany: Paul-Ehrlich-Institut; Netherlands: Medicines Evaluation Board (MEB); Austria: Federal Ministry for Health and Women; Italy: The Italian Medicines Agency; Spain: Spanish Agency of Medicines; United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by ALK-Abelló A/S:

Grass pollen allergy
Hayfever
Allergen immunotherapy
Specific immunotherapy

Study placed in the following topic categories:

Hypersensitivity
Rhinitis, Allergic, Seasonal

ClinicalTrials.gov processed this record on January 16, 2009