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Long-term Efficacy and Safety Study With Oralgen Grass Pollen

NCT00824447 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 356

Last updated 2010-05-05

No results posted yet for this study

Summary

This study is designed to give additional information on the efficacy, safety and local effects (tolerability) of a dose of sublingual immunotherapy administered once a day, during a second grass pollen season.

Conditions

  • Allergic Rhinoconjunctivitis

Interventions

DRUG

Oralgen

allergen solution sublingually

OTHER

placebo

placebo control

Sponsors & Collaborators

  • Artu Biologicals

    lead INDUSTRY

Principal Investigators

  • Dyonne van Duren, MD, PhD · AMPHA Nijmegen, Toernooiveld 220, 6525EC, Nijmegen, The Netherlands

  • Knut Schaekel, MD, PhD · Universitait Klinikum Carl Gustav Carus, Fetscherstrasse 74, SN 01307, Dresden, Germany

  • Iveta Kozlovska, MD, PhD · Centrum Immunologie a allergologie, Pavla Horova 14, 84108 Bratislava, Slovak Republic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2007-08-31
Primary Completion
2008-08-31
Completion
2009-01-31

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 NCT00824447 on ClinicalTrials.gov