Tolerability of ALK Grass Tablet in Children

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

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
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 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

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

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
Please refer to this study by its identifier: NCT00310453

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

No publications provided Identifier: NCT00310453     History of Changes
Other Study ID Numbers: GT-09
Study First Received: April 2, 2006
Last Updated: May 3, 2006
Health Authority: Spain: Spanish Agency of Medicines processed this record on April 17, 2014