NCT00409409

Efficacy and Safety of 300 IR Sublingual Immunotherapy (SLIT) Tablets in Children Suffering From Grass Pollen Rhinoconjunctivitis

A Randomised, Double-blind, Placebo-controlled, Multi-national, Multi-centre, Phase III Paediatric Study of the Efficacy and Safety of 300 IR Sublingual Immunotherapy (SLIT) Administered as Allergen-based Tablets Once Daily to Children Suffering From Grass Pollen Rhinoconjunctivitis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 278 (actual)
• Sponsor: Stallergenes Greer · Industry
• Sex: All
• Age: 5 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

A phase III study to evaluate the efficacy and safety of SLIT for grass pollen allergens compared with placebo for reduction of symptoms and rescue medication usage in children.

Conditions

• Allergy

Interventions

Type	Name	Description
DRUG	300 IR grass pollen allergen extract tablet	One sublingual tablet daily during 4 months before pollen season and during pollen season
DRUG	Placebo tablet	One sublingual tablet daily during 4 months before pollen season and during pollen season

Timeline

• Start date: 2006-12-01
• Primary completion: 2007-09-01
• Completion: 2007-09-01
• First posted: 2006-12-08
• Last updated: 2016-05-26
• Results posted: 2016-05-26

Locations

1 site across 1 country: Germany