Safety and Tolerability Study of Ragweed SLIT Tablets

November 5, 2010 updated by: Stallergenes Greer

Phase I Study to Investigate the Safety, Tolerability and Pharmacodynamic Effects of Sublingual Immunotherapy Tablets Given in Single Rising Doses and in Multi Dose Regimens to Subjects With an Allergy to Ragweed Pollen.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hungary
      • Balatonfüred, Hungary, H-8230
        • DRC Drug Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • written consent
  • male or female subjects from 18 yo 60 years old and in general good health
  • for women of child bearing potential: negative urine pregnancy test and use of medically effective contraceptive method
  • symptoms of ragweed pollen induced allergic rhinitis for at least the last 2 years
  • sensitization to ragweed pollen as demonstrated with positive skin prick test to ragweed pollen and specific IgE level (ragweed pollen) > 0.70 kU/l at screening
  • FEV1 at least of 80% of predicted value at screening

Exclusion Criteria:

  • past or current disease which, as judged by the investigator, may affect the outcome of this study
  • history of life-threatening asthma
  • asthma requiring daily treatment (whatever the pharmaceutical class)
  • pregnant or lactating women
  • subjects who previously received desensitisation treatment to ragweed pollen and/or other Asteraceae or who plan to start desensitisation treatment during this study
  • symptoms during the treatment phase due to a sensitivity to a second allergen
  • subjects treated with ongoing immunotherapy with another allergen

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 2
Drug: Sublingual tablet of ragweed pollen allergen extract
administered once a day over 10 days
PLACEBO_COMPARATOR: 1
Drug: Sublingual tablet of ragweed pollen allergen extract
administered once a day over 10 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety, tolerability as indicated by adverse events and safety laboratory evaluation assessed every day over 2 weeks
Time Frame: 2 weeks
2 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Immunological markers (IgE and IgG4)
Time Frame: 2 weeks
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stallergenes Greer

Collaborators

Quintiles, Inc.

Investigators

  • Principal Investigator: Eva Péterfai, MD, DRC Drug Research Center, Balatonfüred - Hungary

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (ACTUAL)

April 1, 2009

Study Completion (ACTUAL)

October 1, 2009

Study Registration Dates

First Submitted

October 13, 2010

First Submitted That Met QC Criteria

October 19, 2010

First Posted (ESTIMATE)

October 20, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

November 7, 2010

Last Update Submitted That Met QC Criteria

November 5, 2010

Last Verified

October 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VO63.08 HUN

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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