NCT00812799

A Randomised, Double-blind, Placebo Controlled Study With Oralgen Grass Pollen Rhinoconjunctivitis

A Randomised Double Blind Placebo-controlled, Long-term Phase III Study to Assess the Efficacy and Safety of Oralgen Grass Pollen in Patients With Grass Pollen Related Allergic Rhinoconjunctivitis

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 374 (actual)
• Sponsor: Artu Biologicals · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

This study will be performed to determine the long-term efficacy of 19.000 BU Oralgen grass pollen administered daily in patients with grass pollen related allergic rhinoconjunctivitis.

Detailed description

Patients between 18 and 60 years will be randomized to receive either Oralgen grass pollen or placebo administered sublingually once a day. Treatment will start at least 16 weeks prior to the anticipated start of the pollen season 2009 and will last until the end of the pollen season 2011. Study medication will be titrated during the first period of treatment until maintenance dose has been reached.

Conditions

• Allergic Rhinoconjunctivitis

Interventions

Type	Name	Description
DRUG	Oralgen	19.000 BU daily
OTHER	placebo control	placebo control

Timeline

• Start date: 2008-12-01
• Primary completion: 2011-08-01
• Completion: 2011-12-01
• First posted: 2008-12-22
• Last updated: 2010-04-30

Locations

60 sites across 6 countries: Belgium, France, Germany, Netherlands, Poland, United Kingdom