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Phase III Study to Assess the Long Term Efficacy, Carry-over Effect and Safety of 300 IR Sublingual Immunotherapy Tablets

NCT00418379 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 633

Last updated 2016-05-25

Study results available
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Summary

A phase III study to evaluate Long term efficacy , carry-over effect and safety of 300 IR sublingual Immunotherapy (SLIT) tablets in adults patients suffering from grass pollen rhinoconjunctivitis

Conditions

  • Allergy

Interventions

DRUG

300 IR (4M)

300 IR grass pollen allergen extract tablet starting 4 months before the pollen season

DRUG

300 IR (2M)

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

DRUG

Placebo

Placebo tablet

Sponsors & Collaborators

  • Stallergenes Greer

    lead INDUSTRY

Principal Investigators

  • Alain DIDIER, MD, Pr · Hôpital Rangueil-Larrey, Toulouse, France

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-12-31
Primary Completion
2010-08-31
Completion
2011-09-30

Countries

  • France

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 NCT00418379 on ClinicalTrials.gov