NCT00418379

Phase III Study to Assess the Long Term Efficacy, Carry-over Effect and Safety of 300 IR Sublingual Immunotherapy Tablets

A Randomised, Double-blind, Placebo-controlled, Multi-national, Multi-centre, Phase III Study to Assess the Long Term Efficacy, Carry-over Effect and Safety of Two Dosing Regimens of 300 IR Sublingual Immunotherapy (SLIT) Administered as Allergen-based Tablets Once Daily to Patients Suffering From Grass Pollen Rhinoconjunctivitis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 633 (actual)
• Sponsor: Stallergenes Greer · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

A phase III study to evaluate Long term efficacy , carry-over effect and safety of 300 IR sublingual Immunotherapy (SLIT) tablets in adults patients suffering from grass pollen rhinoconjunctivitis

Conditions

• Allergy

Interventions

Type	Name	Description
DRUG	300 IR (4M)	300 IR grass pollen allergen extract tablet starting 4 months before the pollen season
DRUG	300 IR (2M)	300 IR grass pollen allergen extract tablet starting 2 months before the pollen season
DRUG	Placebo	Placebo tablet

Timeline

• Start date: 2006-12-01
• Primary completion: 2010-08-01
• Completion: 2011-09-01
• First posted: 2007-01-04
• Last updated: 2016-05-25
• Results posted: 2016-05-25

Locations

1 site across 1 country: France