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Evaluation of Safety and Efficacy of Specific Immunotherapy With Recombinant Major Allergens of Timothy Grass Pollen Adsorbed Onto Aluminium-hydroxide in Patients With IgE-mediated Allergic Rhinoconjunctivitis +/- Controlled Asthma (AMETHYST)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00671268
First Posted: May 5, 2008
Last Update Posted: November 8, 2013
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 (Responsible Party):
Allergopharma GmbH & Co. KG
  Purpose
Efficacy and Safety from a high-dosed subcutaneous recombinant preparation

Condition Intervention Phase
Rhinoconjunctivitis Biological: AL0704rP Biological: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Multicentre, Multinational Randomised DBPC Clinical Trial for Evaluation of Safety and Efficacy of Specific Immunotherapy With Recombinant Major Allergens of Timothy Grass Pollen Adsorbed Onto Aluminium-hydroxide in Patients With IgE-mediated Allergic Rhinoconjunctivitis +/- Controlled Asthma

Resource links provided by NLM:


Further study details as provided by Allergopharma GmbH & Co. KG:

Primary Outcome Measures:
  • Change of Symptom and Medication score [ Time Frame: during the baseline and the following two pollen seasons ]

Enrollment: 256
Study Start Date: March 2008
Study Completion Date: March 2013
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
strict subcutaneous
Biological: AL0704rP
strict subcutaneous
Other Name: "na"
Placebo Comparator: 2
strict subcutaneous
Biological: Placebo
strict subcutaneous
Other Name: "na"

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Allergic rhinoconjunctivitis attributable to grass pollen
  • Positive SPT
  • Positive EAST
  • Positive provocation test

Exclusion Criteria:

  • serious disease
  • other perennial allergies
  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): NCT00671268


Locations
Germany
Allergopharma GmbH & Co. KG
Reinbek, Germany
Sponsors and Collaborators
Allergopharma GmbH & Co. KG
Investigators
Principal Investigator: Margitta Worm, Professor
  More Information

Additional Information:
Responsible Party: Allergopharma GmbH & Co. KG
ClinicalTrials.gov Identifier: NCT00671268     History of Changes
Other Study ID Numbers: AL0704rP
2007-003208-37 ( EudraCT Number )
First Submitted: April 23, 2008
First Posted: May 5, 2008
Last Update Posted: November 8, 2013
Last Verified: November 2013

Keywords provided by Allergopharma GmbH & Co. KG:
Grass pollen allergy
specific immunotherapy

Additional relevant MeSH terms:
Conjunctivitis
Conjunctivitis, Allergic
Conjunctival Diseases
Eye Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Aluminum Hydroxide
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Antacids
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents