Tolerability of ALK Grass Tablet in Children

This study has been completed.
Sponsor:
Information provided by:
ALK-Abelló A/S
ClinicalTrials.gov Identifier:
NCT00310453
First received: April 2, 2006
Last updated: May 3, 2006
Last verified: May 2006

April 2, 2006
May 3, 2006
March 2006
Not Provided
Assessment of safety by recording of adverse events
Same as current
Complete list of historical versions of study NCT00310453 on ClinicalTrials.gov Archive Site
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Tolerability of ALK Grass Tablet in Children
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)

The purpose of this trial is to assess whether the ALK Grass tablet treatment is safe to use in children aged 5-12 years

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Allergy
Biological: ALK Grass tablet
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
32
May 2006
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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
Both
5 Years to 12 Years
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT00310453
GT-09
Not Provided
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ALK-Abelló A/S
Not Provided
Study Director: Kim Simonsen, MD ALK-Abelló A/S, Boege Alle 6-8, 2970 Hoersholm, Denmark
ALK-Abelló A/S
May 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP