drugset / Trial / NCT00803244

Safety and Efficacy on Phase III Study on 300 IR SLIT to Patients Suffering From Grass Pollen Rhinoconjunctivitis

NCT00803244 ↗

Phase 3 Completed 381 enrolled Stallergenes Greer
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to evaluate the efficacy and safety of sublingual tablets of grass pollen allergen extract when initiated 2 months before the grass pollen season compared with placebo for reduction of rhinoconjunctivitis symptoms and rescue medication usage.

Timeline

Start
2009-01
Primary completion
2009-08
Completion
2010-01

Outcome

Missed primary endpoint

registry analysis (superiority or other test); 300 IR vs Placebo; p = 0.2344; Difference in LS Means -0.49 (95% CI -1.30 to 0.32); ANCOVA NCT00803244 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject 300 IR Unknown 300 unknown Other

Indications

No indication recorded.