CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 473 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/NCT00955825
NCT00955825Phase 3Completed
CompareCT.gov

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

Stallergenes Greer·interventional·Posted Aug 10, 2009·Updated May 19, 2016

In Brief

A Phase 3 clinical trial evaluating 300 IR and Placebo for Allergic Rhinitis Due to Grass Pollens. Completed, enrolled 473 participants across 19 sites.

Detailed Summary

The purpose of the study is to assess the efficacy and safety of 300 IR sublingual tablet of grass pollen allergen extract compared to placebo in adult patient with allergic rhinoconjunctivitis.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAllergic Rhinitis Due to Grass Pollens
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedAug 10, 2009
Enrollment StartOct 1, 2008
Primary CompletionAug 1, 2009
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 16.9 years ago

Interventions

300 IRdrug

300 IR grass pollen allergen extract tablet taken daily for approximately 6 months starting 4 months before the grass pollen season and over the grass pollen season

Placebodrug

Placebo sublingual tablet taken daily for approximately 6 months starting 4 months before the grass pollen season and over the grass pollen season