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

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ClinicalTrials.gov Identifier: NCT00773240
Recruitment Status : Completed
First Posted : October 16, 2008
Last Update Posted : August 30, 2011
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Grass Pollen Allergy Drug: Grazax Drug: placebo Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 276 participants
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
Study Start Date : April 2008
Primary Completion Date : October 2008
Study Completion Date : February 2009
Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

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

Eligibility Criteria

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:

  • 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 Posted: October 16, 2008    Key Record Dates
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