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Tolerability of ALK Grass Tablet in Children

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00310453
First Posted: April 4, 2006
Last Update Posted: May 4, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
ALK-Abelló A/S
  Purpose
The purpose of this trial is to assess whether the ALK Grass tablet 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
Intervention Model: Parallel Assignment
Masking: Double
Official Title: A Randomised, Double-Blind, Placebo-Controlled, Multi-Centre Phase I Trial Investigating the Safety of ALK Grass Tablet in Children Aged 5-12 Years With Grass Pollen Induced Rhinoconjunctivitis (With/Without Asthma)

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

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

Estimated Enrollment: 32
Study Start Date: March 2006
Estimated Study Completion Date: May 2006
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
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:

  • Severe asthma
  • Previous treatment with immunotherapy
  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): NCT00310453


Locations
Spain
Servicio de Alergia, Hospital del Niño Jesús
Madrid, Spain, 28040
Sponsors and Collaborators
ALK-Abelló A/S
Investigators
Study Director: Kim Simonsen, MD ALK-Abelló A/S, Boege Alle 6-8, 2970 Hoersholm, Denmark
  More Information

ClinicalTrials.gov Identifier: NCT00310453     History of Changes
Other Study ID Numbers: GT-09
First Submitted: April 2, 2006
First Posted: April 4, 2006
Last Update Posted: May 4, 2006
Last Verified: May 2006