- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00623701
Efficacy and Safety From a High-dosed Sublingual Grass Pollen Preparation (ALLEGRA6)
November 7, 2013 updated by: Allergopharma GmbH & Co. KG
A Multicentre, Multinational, Placebo-controlled, Double-blind, Randomized Study to Evaluate Efficacy and Safety of a Perennial, Sublingual, Specific Immunotherapy in Patients With Rhinoconjunctivitis With/Without Controlled Asthma Caused by Grass Pollen
Efficacy and Safety from a high-dosed sublingual grass pollen preparation
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
126
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Hamburg, Germany, 20354
- Prof. Kristian Reich, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Allergic rhinoconjunctivitis attributable to grass pollen
- Positive SPT
- Positive EAST
- Positive provocation Test
Exclusion Criteria:
- Serious chronic disease
- other perennial allergies
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: 1
sublingual placebo preparation
|
sublingual placebo preparation, daily
Sublingual preparation, 40 micro grams Phl p 5 maintenance dose,daily
|
Experimental: 2
Sublingual preparation, 40 micro grams Phl p 5 maintenance dose
|
sublingual placebo preparation, daily
Sublingual preparation, 40 micro grams Phl p 5 maintenance dose,daily
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Symptom and Medication Score
Time Frame: Grass pollen season 2009
|
Grass pollen season 2009
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Kristian Reich, Professor, Not Affiliated
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2008
Primary Completion (Actual)
October 1, 2011
Study Completion (Actual)
October 1, 2012
Study Registration Dates
First Submitted
February 19, 2008
First Submitted That Met QC Criteria
February 25, 2008
First Posted (Estimate)
February 26, 2008
Study Record Updates
Last Update Posted (Estimate)
November 8, 2013
Last Update Submitted That Met QC Criteria
November 7, 2013
Last Verified
November 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AL0703st
- 2007-000823-16 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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