Efficacy and Safety Study Of Short Ragweed Pollen Sublingual-Oral Immunotherapy
NCT ID: NCT01353079
Last Updated: 2015-02-05
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
429 participants
INTERVENTIONAL
2011-04-30
2012-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Short Ragweed Pollen Allergenic Extract
Short Ragweed Pollen Allergenic Extract
Daily sublingual administration of Short Ragweed Pollen Allergenic Extract up to 42 U Amb a 1 for a minimum of 8 weeks prior to the ragweed pollen season.
Glycero-COCAs
Placebo
Placebo: Glycero-COCAs sublingual
Interventions
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Short Ragweed Pollen Allergenic Extract
Daily sublingual administration of Short Ragweed Pollen Allergenic Extract up to 42 U Amb a 1 for a minimum of 8 weeks prior to the ragweed pollen season.
Placebo
Placebo: Glycero-COCAs sublingual
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* history of anaphylaxis
* subject with chronic sinusitis, unstable angina, significant arrhythmia, uncontrolled hypertension, or other chronic or immunological disease
* Asthmatic subjects with FEV1 or PEF less than or equal to 80% predicted
* Subjects who have received experimental drug within 30 days prior to study admission
* Subjects who have received anit-IgE medications in the last 12 months
* Subjects who have received ragweed immunotherapy in the last 3 years
* Subjects who are currently users of inhaled, intramuscular, or intravenous corticosteroids, tricyclic anti-depressants, beta blockers, and MAO inhibitors
* Subjects refusing to sign epi-pen training form
* Females who are pregnant or breast feeding
18 Years
55 Years
ALL
No
Sponsors
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Greer Laboratories
INDUSTRY
Responsible Party
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Locations
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Site 7
Warrenton, Virginia, United States
Countries
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Other Identifiers
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SLIT10-01
Identifier Type: -
Identifier Source: org_study_id
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