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Safety of ALK Ragweed Tablet

This study has been completed.
Sponsor:
Information provided by:
ALK-Abelló A/S
ClinicalTrials.gov Identifier:
NCT00330083
First received: May 23, 2006
Last updated: September 20, 2007
Last verified: September 2007
History of Changes
  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
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
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:

MedlinePlus related topics: Allergy
U.S. FDA Resources

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

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00330083     History of Changes
Other Study ID Numbers: RT-01
Study First Received: May 23, 2006
Last Updated: September 20, 2007
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on May 16, 2013