CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 381 enrolled
Drug / intervention
300 IR +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00803244
NCT00803244Phase 3Completed

A Randomised, Double-blind, Placebo-controlled, Multi National, Phase III Study of the Efficacy and Safety of 300 IR Sublingual Immunotherapy (SLIT) Tablet, Starting 2 Months Before the Grass Pollen Season Once Daily to Patients Suffering From Grass Pollen Rhinoconjunctivitis

Stallergenes Greer·interventional·Posted Dec 5, 2008·Updated May 25, 2016

In Brief

A Phase 3 clinical trial evaluating 300 IR and Placebo for Primary Disease. Completed, enrolled 381 participants across 6 sites in 3 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPrimary Disease
CountriesFrance, Italy, Spain
Collaborators--

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedDec 5, 2008
Enrollment StartJan 1, 2009
Primary CompletionAug 1, 2009
Study CompletionJan 1, 2010
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 17.6 years ago

Interventions

300 IRdrug

300 IR grass pollen allergen extract tablet starting 2 months before the grass pollen season and during the grass pollen season

Placebodrug

Placebo sublingual tablet starting 2 months before the grass pollen season and during the grass pollen season