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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
ALK-Abelló A/S
ClinicalTrials.gov Identifier:
NCT00773240
First received: October 15, 2008
Last updated: August 27, 2011
Last verified: August 2011
  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
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Pharmacodynamics - Immunological assessments [ Time Frame: Pre- and post treatment ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

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

No publications provided by ALK-Abelló A/S

Additional 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
Study First Received: October 15, 2008
Last Updated: August 27, 2011
Health Authority: Germany: Paul-Ehrlich-Institut

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

ClinicalTrials.gov processed this record on July 24, 2014