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Efficacy and Safety of Sublingual Tablets of Grass Pollen Allergen Extract

NCT00619827 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 89

Last updated 2016-05-23

Study results available
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Summary

The objective of this study is to assess the effect of grass pollen extract SLIT tablets on the Rhinoconjunctivitis Total Symptom Score (RTSS) of the six rhinoconjunctivitis symptoms in response to grass pollen challenge after one week, one, two and four months of treatment in patients suffering from Seasonal Allergic Rhinoconjunctivitis (SAR) due to grass pollen.

Conditions

  • Seasonal Allergic Rhinitis

Interventions

DRUG

300 IR grass pollen allergen extract tablet

300 IR grass pollen allergen extract tablet once daily during four months

DRUG

Placebo tablet

Placebo tablet once daily during four months

Sponsors & Collaborators

  • Stallergenes Greer

    lead INDUSTRY

Principal Investigators

  • Friedrich HORAK, Pr. MD · Allergy Center Vienna West, VIENNA, AUSTRIA

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
2007-09-30
Primary Completion
2008-03-31
Completion
2008-03-31

Countries

  • Austria

Study Locations

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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 NCT00619827 on ClinicalTrials.gov