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

NCT00803244 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 381

Last updated 2016-05-25

Study results available
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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.

Conditions

  • Primary Disease

Interventions

DRUG

300 IR

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

DRUG

Placebo

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

Sponsors & Collaborators

  • Stallergenes Greer

    lead INDUSTRY

Principal Investigators

  • DE BLAY Frédéric, MD · NHC, Hôpitaux Universitaires de Strasbourg

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2009-08-31
Completion
2010-01-31

Countries

  • France
  • Italy
  • Spain

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00803244 on ClinicalTrials.gov