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Safety of ALK Ragweed Tablet

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00330083
First Posted: May 25, 2006
Last Update Posted: September 21, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
ALK-Abelló A/S
  Purpose
This trial is performed to assess whether ALK Ragweed Tablet is safe to use in adults

Condition Intervention Phase
Allergy Biological: ALK Ragweed Tablet Phase 1

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by ALK-Abelló A/S:

Primary Outcome Measures:
  • Assessment of safety by recording of adverse events

Estimated Enrollment: 72
Study Start Date: May 2006
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00330083


Locations
United States, Texas
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.
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00330083     History of Changes
Other Study ID Numbers: RT-01
First Submitted: May 23, 2006
First Posted: May 25, 2006
Last Update Posted: September 21, 2007
Last Verified: September 2007

Additional relevant MeSH terms:
Hypersensitivity
Immune System Diseases