Tolerability of ALK Grass Tablet in Children

This study has been completed.

First Received: April 2, 2006 Last Updated: May 3, 2006 History of Changes

Sponsored by:	ALK-Abelló A/S
Information provided by:	ALK-Abelló A/S
ClinicalTrials.gov Identifier:	NCT00310453

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 I

Study Type:	Interventional
Study Design:	Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety Study
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:

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

Eligibility

Criteria

Inclusion Criteria:

Exclusion Criteria:

Contacts and Locations

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

Study ID Numbers:	GT-09
Study First Received:	April 2, 2006
Last Updated:	May 3, 2006
ClinicalTrials.gov Identifier:	NCT00310453 History of Changes
Health Authority:	Spain: Spanish Agency of Medicines

Study placed in the following topic categories:

Hypersensitivity
Asthma

ClinicalTrials.gov processed this record on May 07, 2009