Tolerability of ALK Grass Tablet in Children

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

Completed

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Key information

Conditions

Allergy Hypersensitivity Immune System Diseases

Age range

5 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Servicio de Alergia, Hospital del Niño Jesús

Madrid, 28040, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ALK Grass tablet

Biological

Primary outcomes

Assessment of safety by recording of adverse events

Sponsors and collaborators

Lead sponsor

ALK-Abelló A/S

Industry

Registry information

Official study 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)

Important dates

Study start: 2006
Study completion: 2006
First posted: Apr 4, 2006
Registry last updated: May 4, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed