ClinicalTrials.gov
ClinicalTrials.gov Menu

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)

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.
ClinicalTrials.gov Identifier: NCT00671268
Recruitment Status : Completed
First Posted : May 5, 2008
Last Update Posted : November 8, 2013
Sponsor:
Information provided by (Responsible Party):
Allergopharma GmbH & Co. KG

Brief Summary:
Efficacy and Safety from a high-dosed subcutaneous recombinant preparation

Condition or disease Intervention/treatment Phase
Rhinoconjunctivitis Biological: AL0704rP Biological: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 256 participants
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
Study Start Date : March 2008
Actual Primary Completion Date : March 2012
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 1
strict subcutaneous
Biological: AL0704rP
strict subcutaneous
Other Name: "na"

Placebo Comparator: 2
strict subcutaneous
Biological: Placebo
strict subcutaneous
Other Name: "na"




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


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 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

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

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 Posted: May 5, 2008    Key Record Dates
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