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
  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
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
  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:

  • Severe asthma
  • 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: 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

No publications provided

ClinicalTrials.gov 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

ClinicalTrials.gov processed this record on July 24, 2014