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A Phase III Trial Assessing the Pharmacodynamic Effect and the Tolerability of Grazax Treatment

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00773240
First Posted: October 16, 2008
Last Update Posted: August 30, 2011
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 (Responsible Party):
ALK-Abelló A/S
  Purpose
The study assess the pharmacodynamic effect and the tolerability of Grazax treatment initiated in the grass pollen season in subjects with seasonal grass pollen induced rhinoconjunctivitis

Condition Intervention Phase
Grass Pollen Allergy Drug: Grazax Drug: placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Phase III Trial Assessing the Pharmacodynamic Effect and the Tolerability of Grazax Treatment Initiated in the Grass Pollen Season in Subjects With Seasonal Grass Pollen Induced Rhinoconjunctivitis

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

Primary Outcome Measures:
  • Pharmacodynamics - Immunological assessments [ Time Frame: Pre- and post treatment ]

Enrollment: 276
Study Start Date: April 2008
Study Completion Date: February 2009
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Grazax
Drug: Grazax
1 tablet, 75,000 SQ-T, daily during the trial period
Placebo Comparator: 2 Drug: placebo
1 placebo tablet, matching the active treatment, daily during the trial period

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:

  • Positive skin prick test to Phleum pratense
  • Positive IgE to Phleum pratense
  • signed informed consent
  • A clinical history of moderate to severe persistent rhinoconjunctivitis symptoms

Exclusion Criteria:

  • No uncontrolled asthma in the past 12 months
  • No history of an IgE mediated systemic reaction due to food, insect venom, any kind of medication or induced by exercise, where there are symptoms both from the skin and the respiratory system with or without hypotension
  • No history of an IgE mediated systemic reaction due to food, insect venom, any kind of medication or induced by exercise, where there are symptoms both from the skin and the respiratory system with or without hypotension
  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): NCT00773240


Locations
Denmark
ALK-Abello A/S, Bøge alle 6-8
Hørsholm, Denmark, DK-2970
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: ALK-Abelló A/S
ClinicalTrials.gov Identifier: NCT00773240     History of Changes
Other Study ID Numbers: GT-18
First Submitted: October 15, 2008
First Posted: October 16, 2008
Last Update Posted: August 30, 2011
Last Verified: August 2011

Additional relevant MeSH terms:
Rhinitis, Allergic, Seasonal
Rhinitis, Allergic
Rhinitis
Nose Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Otorhinolaryngologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases