Safety and Efficacy of Grass Pollen Allergoid in the Treatment of Allergic Rhinoconjunctivitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergopharma GmbH & Co. KG
ClinicalTrials.gov Identifier:
NCT00263601
First received: December 8, 2005
Last updated: January 23, 2014
Last verified: January 2014

December 8, 2005
January 23, 2014
November 2001
May 2004   (final data collection date for primary outcome measure)
  • Symptom and Medication Score [ Time Frame: During the grass pollen season ] [ Designated as safety issue: No ]
  • Patient documentation in a diary [ Time Frame: During the grass pollen season ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00263601 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Safety and Efficacy of Grass Pollen Allergoid in the Treatment of Allergic Rhinoconjunctivitis
A Multicentre, Placebo Controlled, Double-Blind Study for Evaluation of Safety and Efficacy of Preseasonal Specific Immunotherapy With an Allergoid Preparation of an Extract of a 6 Grass Pollen Mixture in Patients With Clinically Relevant Grass Pollen Sensitivity

The trial is performed to assess efficacy and safety of the Grass Pollen Allergoid in Allergic Rhinoconjunctivitis

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Grass Pollen Allergy
Biological: Grass pollen Allergoid
Subcutaneous injections
  • Experimental: Active
    Biological /Vaccine
    Intervention: Biological: Grass pollen Allergoid
  • Placebo Comparator: Placebo
    Intervention: Biological: Grass pollen Allergoid

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
150
August 2010
May 2004   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Positive Skin Prick test to grass pollen
  • Positive RAST to grass pollen
  • Positive specific provocation test to grass pollen

Exclusion Criteria:

  • Serious chronic diseases
  • Other perennial allergies
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00263601
Al0101av
No
Allergopharma GmbH & Co. KG
Allergopharma GmbH & Co. KG
Not Provided
Principal Investigator: Annemie Narkus, M.D.
Allergopharma GmbH & Co. KG
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP