Safety and Tolerability Study of Ragweed SLIT Tablets

NCT01224834 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2010-11-08

No results posted yet for this study

Summary

The purpose of this study is to determine the safety and tolerability of several doses of ragweed pollen allergen extract administered as sublingual tablets in subjects with allergic rhinitis to ragweed.

Conditions

  • Rhinitis, Allergic, Seasonal
  • Ragweed Pollen Allergy

Interventions

DRUG

Sublingual tablet of ragweed pollen allergen extract

administered once a day over 10 days

Sponsors & Collaborators

  • Quintiles, Inc.

    collaborator INDUSTRY
  • Stallergenes Greer

    lead INDUSTRY

Principal Investigators

  • Eva Péterfai, MD · DRC Drug Research Center, Balatonfüred - Hungary

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2009-04-30
Completion
2009-10-31

Countries

  • Hungary

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 NCT01224834 on ClinicalTrials.gov