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Efficacy and Safety of Grass Pollen Sublingual Immunotherapy

NCT00567346 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 605

Last updated 2010-05-05

No results posted yet for this study

Summary

The study is assessing efficacy and safety of three different dosage regimens of grass pollen sublingual immunotherapy in adult patients suffering from grass pollen related rhinoconjunctivitis.

Conditions

  • Allergic Rhinoconjunctivitis

Interventions

DRUG

Oralgen

Patients will receive drops of grass pollen immunotherapy sublingually

DRUG

grass pollen extract

Patients will receive matching placebo sublingually

Sponsors & Collaborators

  • Artu Biologicals

    lead INDUSTRY

Principal Investigators

  • Folkert R Roossien · Artu-Biologicals Europe B.V., the Netherlands

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2006-12-31
Primary Completion
2007-10-31
Completion
2008-03-31

Countries

  • Bulgaria
  • Czechia
  • Germany
  • Hungary
  • Lithuania
  • Netherlands
  • Slovakia

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 NCT00567346 on ClinicalTrials.gov