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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
  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:


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
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: 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

ClinicalTrials.gov processed this record on November 27, 2014