Tolerability of ALK Grass Tablet in Children

Allergy Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00310453
• Other study ID #: GT-09
• Status: Completed
• Phase: Phase 1
• First received: April 2, 2006
• Last updated: May 3, 2006
• Start date: March 2006
• Est. completion date: May 2006

Study information

• Verified date: May 2006
• Source: ALK-Abelló A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: May 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years to 12 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double-Blind

Related Conditions & MeSH terms

• Allergy

Intervention

Biological:
• ALK Grass tablet

Locations

Country	Name	City	State
Spain	Servicio de Alergia, Hospital del Niño Jesús	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
ALK-Abelló A/S

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of safety by recording of adverse events