Tolerability of ALK Grass Tablet in Children

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-03-31

Study Completion Date

2006-05-31

Brief Summary

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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

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Conditions

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Allergy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

DOUBLE

Interventions

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ALK Grass tablet

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

Minimum Eligible Age

5 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Kim Simonsen, MD

Role: STUDY_DIRECTOR

ALK-Abelló A/S, Boege Alle 6-8, 2970 Hoersholm, Denmark

Locations

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Servicio de Alergia, Hospital del Niño Jesús

Madrid, , Spain

Site Status

Countries

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Spain

Other Identifiers

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GT-09

Identifier Type: -

Identifier Source: org_study_id