Tolerability of ALK Grass Tablet in Children

Phase 1

Completed

• Conditions: Allergy

• Registration Number: NCT00310453
• Lead Sponsor: ALK-Abelló A/S

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2006-03
• Study First Submitted: 2006-04-02
• Study First Submitted QC: 2006-04-02
• Study First Posted: 2006-04-04
• Status Verified: 2006-05
• Study Completion: 2006-05
• Last Update Submitted: 2006-05-03
• Last Update Posted: 2006-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Assessment of safety by recording of adverse events

Trial Locations

Locations (1)

Servicio de Alergia, Hospital del Niño Jesús; 🇪🇸 Madrid, Spain