Safety of ALK Ragweed Tablet
Sponsor
ALK-Abelló A/S (Industry)
Overall Status
Completed
CT.gov ID
NCT00330083
Collaborator
(none)
72
1
Study Details
Study Description
Brief Summary
This trial is performed to assess whether ALK Ragweed Tablet is safe to use in adults
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
72 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
Double
Primary Purpose:
Treatment
Official Title:
A RANDOMIZED, MULTIPLE DOSE, DOSE-ESCALATION, DOUBLE-BLIND, PLACEBO-CONTROLLED PHASE I TRIAL INVESTIGATING THE OPTIMAL SAFE DOSE OF ALK RAGWEED TABLET AMBROSIA ARTEMISIIFOLIA IN ADULT SUBJECTS WITH SEASONAL RHINOCONJUNCTIVITIS CAUSED BY RAGWEED POLLEN ALLERGY
Study Start Date
:
May 1, 2006
Outcome Measures
Primary Outcome Measures
- Assessment of safety by recording of adverse events []
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 50 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Ragweed pollen induced rhinoconjunctivitis
-
Adults of either sex (18-50 years of age)
-
Positive skin prick test to ragweed
Exclusion Criteria:
- Previous treatment with immunotherapy
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Healthcare Discoveries Inc. | San Antonio | Texas | United States | 78229 |
Sponsors and Collaborators
- ALK-Abelló A/S
Investigators
- Principal Investigator: George J. Atiee, MD, Healthcare Discoveries Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00330083
Other Study ID Numbers:
- RT-01
First Posted:
May 25, 2006
Last Update Posted:
Sep 21, 2007
Last Verified:
Sep 1, 2007
Additional relevant MeSH terms: