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Sponsored by: |
Antigen Laboratories, Inc. |
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Information provided by: | Antigen Laboratories, Inc. |
ClinicalTrials.gov Identifier: | NCT00670384 |
The purpose of this study is to identify an effective dose of allergen-specific immunotherapy for short ragweed (Ambrosia artemisiifolia)administered by an oral/sublingual route.
Condition | Intervention | Phase |
---|---|---|
Allergic Rhinitis |
Biological: Standardized Allergenic Extract, Short Ragweed (Ambrosia artemisiifolia) Biological: Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase 2 Randomized, Placebo-Controlled, Parallel Group, Dose-Ranging Study of Sublingual Immunotherapy in Adults Sensitized to the Standardized Allergenic Extract, Short Ragweed (Ambrosia Artemisiifolia) |
Estimated Enrollment: | 150 |
Arms | Assigned Interventions |
---|---|
Dose Group A: Active Comparator |
Biological: Standardized Allergenic Extract, Short Ragweed (Ambrosia artemisiifolia)
Sublingual drops
|
Dose Group B: Active Comparator |
Biological: Standardized Allergenic Extract, Short Ragweed (Ambrosia artemisiifolia)
Sublingual drops
|
Placebo: Placebo Comparator |
Biological: Placebo
Sublingual drops
|
Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Exclusion Criteria:
Contact: Robert B. Berkowitz, M.D. | 770-592-4210 | BBerkowitz@atlantaallergy.com |
United States, Georgia | |
Rx Research | |
Atlanta, Georgia, United States, 30188 |
Responsible Party: | Antigen Laboratories, Inc. ( Linda Brown/Responsible Head ) |
Study ID Numbers: | ALI001-08 |
Study First Received: | April 29, 2008 |
Last Updated: | April 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00670384 |
Health Authority: | United States: Food and Drug Administration |
SLIT Immunotherapy Short ragweed SAR Seasonal allergic rhinitis |
Otorhinolaryngologic Diseases Respiratory Tract Infections Respiratory Tract Diseases |
SARS Rhinitis, Allergic, Seasonal Rhinitis |
Nose Diseases |