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
  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:


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
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, see Learn About Clinical Studies.

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 August 28, 2014