Text Size

Efficacy and Safety of Grazax in Children

This study has been completed.
Sponsor:
Information provided by:
ALK-Abelló A/S
ClinicalTrials.gov Identifier:
NCT00408616
First received: December 6, 2006
Last updated: March 6, 2009
Last verified: March 2009
History of Changes
  Purpose

The purpose of this study is to investigate if immunotherapy with Grazax is safe and reduces the hayfever symptoms and the use of symptom relieving medications in children during the grass pollen season


Condition Intervention Phase
Allergy
 Biological: Grazax-R
Biological: Grazax Placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase III Trial Investigating the Efficacy and Safety of Grazax in Children Aged 5-16 Years With Grass Pollen Induced Rhinoconjunctivitis With or Without Asthma

Resource links provided by NLM:

MedlinePlus related topics: Asthma Hay Fever
U.S. FDA Resources

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

Primary Outcome Measures:
  • Hayfever symptoms [ Time Frame: Grass pollen season 2007 ] [ Designated as safety issue: No ]
  • Intake of hayfever symptom relieving medication [ Time Frame: Grass pollen season 2007 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Combined hayfever symptom and medication scores [ Time Frame: Grass pollen season 2007 ] [ Designated as safety issue: No ]
  • Asthma symptoms and medication [ Time Frame: Grass pollen season 2007 ] [ Designated as safety issue: No ]
  • Global Evaluation of treatment efficacy [ Time Frame: Grass pollen season 2007 ] [ Designated as safety issue: No ]
  • Adverse Events [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
  • Pharmacoeconomic Assessment [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • Immunological Assessment [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Enrollment: 253
Study Start Date: November 2006
Study Completion Date: November 2007
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Grazax treatment
 Biological: Grazax-R
Grass tablet, 75.000 SQ per day for one year
Placebo Comparator: 2
Grazax Placebo
 Biological: Grazax Placebo
Grazax Placebo, 0 SQ tablet per day for one year

  Eligibility

Ages Eligible for Study:   5 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Boys and girls 5-16 years of age
  • A clinical history of grass pollen induced hayfever
  • Positive Skin Prick Test to Phleum pratense
  • Positive specific IgE against Phleum pratense

Exclusion Criteria:

  • History of seasonal hayfever symptoms (and/or asthma) caused by another allergen than Phleum pratense during or overlapping the grass pollen season
  • History of perennial hayfever (and/or asthma) that needs medication due to an allergen to which the child is regularly exposed
  • History of severe asthma
  • Current severe atopic dermatitis
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00408616

Locations
Germany
Tangstedter Landstrasse 77
Hamburg, Germany, 22415
Sponsors and Collaborators
ALK-Abelló A/S
Investigators
Principal Investigator: Friedrich Kaiser, Dr. med. Tangstedter Landstrasse 77, 22415 Hamburg, Germany
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00408616     History of Changes
Other Study ID Numbers: GT-12
Study First Received: December 6, 2006
Last Updated: March 6, 2009
Health Authority: Germany: Paul-Ehrlich-Institut

ClinicalTrials.gov processed this record on May 23, 2013