- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01240954
Comparison of Different Up-dosing Schedules With Osiris
August 26, 2011 updated by: ALK-Abelló A/S
The purpose of this study is to compare different up-dosing schedules with Osiris.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
210
Phase
- Phase 2
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
-
-
-
Kraków, Poland
-
-
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 and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- history of grass pollen allergy
- Positive SPT to grass
- Positive IgE to grass
Exclusion Criteria:
- uncontrolled and severe asthma
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
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: OSIRIS
|
OSIRIS current practice
|
EXPERIMENTAL: OSIRIS other concentration 1
|
OSIRIS new concentration 1
|
EXPERIMENTAL: OSIRIS other concentration 2
|
OSIRIS new concentration 2
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
evaluate the tolerability of different up-dosing schedules
Time Frame: 30 days
|
30 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
patient's satisfaction
Time Frame: 30 days
|
30 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
December 1, 2010
Study Registration Dates
First Submitted
November 11, 2010
First Submitted That Met QC Criteria
November 12, 2010
First Posted (ESTIMATE)
November 15, 2010
Study Record Updates
Last Update Posted (ESTIMATE)
August 29, 2011
Last Update Submitted That Met QC Criteria
August 26, 2011
Last Verified
August 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- OS-I-01
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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