Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
60 participants
INTERVENTIONAL
2009-01-31
2009-10-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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1
Sublingual tablet of ragweed pollen allergen extract
administered once a day over 10 days
2
Sublingual tablet of ragweed pollen allergen extract
administered once a day over 10 days
Interventions
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Sublingual tablet of ragweed pollen allergen extract
administered once a day over 10 days
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
60 Years
ALL
No
Sponsors
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Quintiles, Inc.
INDUSTRY
Stallergenes Greer
INDUSTRY
Responsible Party
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Stallergenes SA
Principal Investigators
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Eva Péterfai, MD
Role: PRINCIPAL_INVESTIGATOR
DRC Drug Research Center, Balatonfüred - Hungary
Locations
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DRC Drug Research Center
Balatonfüred, , Hungary
Countries
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Other Identifiers
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VO63.08 HUN
Identifier Type: -
Identifier Source: org_study_id