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NCT00298701 Clinical Trial

Tolerability of Grazax-R in Children

Allergy Clinical Trial

Official title:
A Randomised, Double-Blind, Placebo-Controlled, Multi-Centre Phase I Trial Investigating the Safety of GRAZAX-R in Children Aged 5-12 Years With Grass Pollen Induced Rhinoconjunctivitis (With/Without Asthma)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00298701
Other study ID # GT-11
Secondary ID
Status Completed
Phase Phase 1
First received March 1, 2006
Last updated May 3, 2006
Start date February 2006
Est. completion date April 2006

Study information
Verified date May 2006
Source ALK-Abelló A/S
Contact n/a
Is FDA regulated No
Health authority Germany: Paul-Ehrlich-Institut
Study type Interventional

Clinical Trial Summary

This trial is performed to assess whether the Grazax-R treatment is safe to use in children aged 5-12 years.

Recruitment information / eligibility
Status Completed
Enrollment 50
Est. completion date April 2006
Est. primary completion date
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:

- Previous treatment with immunotherapy

Study Design

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

Related Conditions & MeSH terms

Intervention

Biological:
• ALK Grass tablet

Locations
Country Name City State
Germany Tangstedter Landstrasse 77 Hamburg

Sponsors (1)
Lead Sponsor Collaborator
ALK-Abelló A/S

Country where clinical trial is conducted

Germany, 

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