drugset / Trial / NCT00408616

Efficacy and Safety of Grazax in Children

NCT00408616 ↗

Phase 3 Completed 253 enrolled ALK-Abelló A/S
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to investigate if immunotherapy with Grazax is safe and reduces the hayfever symptoms and the use of symptom relieving medications in children during the grass pollen season

Timeline

Start
2006-11
Primary completion
2007-09
Completion
2007-11

Outcome

Met primary endpoint

paper The rhinoconjunctivitis symptom and medication scores and the asthma symptom score were all statistically significantly different between the 2 treatment groups. PMID 19130937 ↗

paper The differences in medians relative to placebo were 24%, 34%, and 64% in favor of active treatment. PMID 19130937 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject GRAZAX-R Unknown 75000 unknown Other

Indications