Safety and Efficacy of Grass Pollen Allergoid in the Treatment of Allergic Rhinoconjunctivitis - Full Text View

Sponsored by:	Allergopharma Joachim Ganzer KG
Information provided by:	Allergopharma Joachim Ganzer KG
ClinicalTrials.gov Identifier:	NCT00263601

Purpose

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

Condition	Intervention	Phase
Grass Pollen Allergy	Biological: Grass pollen Allergoid	Phase III

MedlinePlus related topics: Allergy Hay Fever

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	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

Further study details as provided by Allergopharma Joachim Ganzer KG:

Primary Outcome Measures:

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 ]

Estimated Enrollment:	150
Study Start Date:	November 2001
Estimated Study Completion Date:	August 2013
Primary Completion Date:	May 2004 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active: Experimental Biological /Vaccine	Biological: Grass pollen Allergoid Subcutaneous injections
Placebo: Placebo Comparator	Biological: Grass pollen Allergoid Subcutaneous injections

Eligibility

Criteria

Inclusion Criteria:

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00263601

Locations

Germany
Allergopharma Joachim Ganzer KG
Reinbek, Germany, 21465

Sponsors and Collaborators

Allergopharma Joachim Ganzer KG

Investigators

Principal Investigator:

Annemie Narkus, M.D.

unaffiliated

More Information

Leader in specific allergy research and therapy This link exits the ClinicalTrials.gov site

Responsible Party:	Allergopharma Joachim Ganzer KG ( Dr. med. A. Narkus )
Study ID Numbers:	Al0101av
Study First Received:	December 8, 2005
Last Updated:	July 14, 2008
ClinicalTrials.gov Identifier:	NCT00263601
Health Authority:	Germany: Paul-Ehrlich-Institut

Keywords provided by Allergopharma Joachim Ganzer KG:

Allergovit
Grass pollen allergy

Study placed in the following topic categories:

Hypersensitivity
Otorhinolaryngologic Diseases
Respiratory Tract Diseases
Rhinitis, Allergic, Seasonal

Hypersensitivity, Immediate
Rhinitis
Respiratory Hypersensitivity

Additional relevant MeSH terms:

Immune System Diseases
Nose Diseases

ClinicalTrials.gov processed this record on January 16, 2009