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Tolerability of Grazax-R in Children

This study has been completed.
Sponsor:
Information provided by:
ALK-Abelló A/S
ClinicalTrials.gov Identifier:
NCT00298701
First received: March 1, 2006
Last updated: May 3, 2006
Last verified: May 2006
History of Changes
  Purpose

This trial is performed to assess whether the Grazax-R treatment is safe to use in children aged 5-12 years.


Condition Intervention Phase
Allergy
 Biological: ALK Grass tablet
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Official Title: A Randomised, Double-Blind, Placebo-Controlled, Multi-Centre Phase I Trial Investigating the Safety of GRAZAX-R in Children Aged 5-12 Years With Grass Pollen Induced Rhinoconjunctivitis (With/Without Asthma)

Resource links provided by NLM:

MedlinePlus related topics: Allergy
U.S. FDA Resources

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

Primary Outcome Measures:
  • Assessment of safety by recording of adverse events

Estimated Enrollment: 50
Study Start Date: February 2006
Estimated Study Completion Date: April 2006
  Eligibility

Ages Eligible for Study:   5 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Grass pollen induced rhinoconjunctivitis
  • Boys and girls, 5-12 years of age
  • Positive skin prick test to grass pollen

Exclusion Criteria:

  • Previous treatment with immunotherapy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00298701

Locations
Germany
Tangstedter Landstrasse 77
Hamburg, Germany, 22415
Sponsors and Collaborators
ALK-Abelló A/S
Investigators
Study Director: Kim Simonsen, MD ALK-Abelló A/S
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00298701     History of Changes
Other Study ID Numbers: GT-11
Study First Received: March 1, 2006
Last Updated: May 3, 2006
Health Authority: Germany: Paul-Ehrlich-Institut

Keywords provided by ALK-Abelló A/S:
Allergy

Additional relevant MeSH terms:
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on June 18, 2013