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Safety and Tolerability Study of Ragweed SLIT Tablets

This study has been completed.
Sponsor:
Collaborator:
Quintiles
Information provided by:
Stallergenes
ClinicalTrials.gov Identifier:
NCT01224834
First received: October 13, 2010
Last updated: November 5, 2010
Last verified: October 2010
History of Changes

October 13, 2010
November 5, 2010
January 2009
April 2009   (final data collection date for primary outcome measure)
Safety, tolerability as indicated by adverse events and safety laboratory evaluation assessed every day over 2 weeks [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01224834 on ClinicalTrials.gov Archive Site
Immunological markers (IgE and IgG4) [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Safety and Tolerability Study of Ragweed SLIT Tablets
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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Rhinitis, Allergic, Seasonal
  • Ragweed Pollen Allergy
Drug: Sublingual tablet of ragweed pollen allergen extract
administered once a day over 10 days
  • Placebo Comparator: 1
    Intervention: Drug: Sublingual tablet of ragweed pollen allergen extract
  • Experimental: 2
    Intervention: Drug: Sublingual tablet of ragweed pollen allergen extract
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
October 2009
April 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
Hungary
 
NCT01224834
VO63.08 HUN
No
Olivier de Beaumont/Medical Director, Stallergenes SA
Stallergenes
Quintiles
Principal Investigator: Eva Péterfai, MD DRC Drug Research Center, Balatonfüred - Hungary
Stallergenes
October 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP