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A Trial of Grazax in Subjects With Hayfever

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00421655
First Posted: January 12, 2007
Last Update Posted: June 24, 2015
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:
ALK-Abelló A/S
  Purpose
The trial is performed to evaluate the efficacy and safety of specific immunotherapy with Grazax for treatment of grass pollen induced allergy.

Condition Intervention Phase
Allergy Drug: Grazax Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase III Trial Assessing the Efficacy and Safety of Grazax in Subjects With Seasonal Grass Pollen Induced Rhinoconjunctivitis With or Without Asthma

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

Primary Outcome Measures:
  • Recording of allergy symptoms [ Time Frame: Grass pollen season 2007 ]

Enrollment: 329
Study Start Date: December 2006
Study Completion Date: October 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Grazax
Tablets 75,000 SQT and matching placebo. One tablet daily.
Placebo Comparator: 2 Drug: Grazax
Tablets 75,000 SQT and matching placebo. One tablet daily.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • History of grass pollen allergy
  • Positive skin prick test to grass
  • Positive specific IgE to grass

Exclusion Criteria

  • FEV1 <70% of predicted value
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00421655


Locations
United States, Iowa
CompleWare Corporation
Iowa City, Iowa, United States, 52244-3090
Sponsors and Collaborators
ALK-Abelló A/S
Investigators
Study Director: Kim Simonsen, MD ALK-Abelló A/S
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Kim Simonsen, MD, Senior Director, ALK-Abello
ClinicalTrials.gov Identifier: NCT00421655     History of Changes
Other Study ID Numbers: GT-14
First Submitted: January 11, 2007
First Posted: January 12, 2007
Last Update Posted: June 24, 2015
Last Verified: June 2015