- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00310453
Tolerability of ALK Grass Tablet in Children
May 3, 2006 updated by: ALK-Abelló A/S
A Randomised, Double-Blind, Placebo-Controlled, Multi-Centre Phase I Trial Investigating the Safety of ALK Grass Tablet in Children Aged 5-12 Years With Grass Pollen Induced Rhinoconjunctivitis (With/Without Asthma)
The purpose of this trial is to assess whether the ALK Grass tablet treatment is safe to use in children aged 5-12 years
Study Overview
Study Type
Interventional
Enrollment
32
Phase
- Phase 1
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
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Madrid, Spain, 28040
- Servicio de Alergia, Hospital del Niño Jesús
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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
5 years to 12 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Grass pollen induced rhinoconjunctivitis
- Boys and girls, 5-12 years of age
- Positive skin prick test to grass pollen
Exclusion Criteria:
- Severe asthma
- Previous treatment with immunotherapy
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
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Assessment of safety by recording of adverse events
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Kim Simonsen, MD, ALK-Abelló A/S, Boege Alle 6-8, 2970 Hoersholm, Denmark
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, 2006
Study Completion
May 1, 2006
Study Registration Dates
First Submitted
April 2, 2006
First Submitted That Met QC Criteria
April 2, 2006
First Posted (Estimate)
April 4, 2006
Study Record Updates
Last Update Posted (Estimate)
May 4, 2006
Last Update Submitted That Met QC Criteria
May 3, 2006
Last Verified
May 1, 2006
More Information
Terms related to this study
Other Study ID Numbers
- GT-09
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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Clinical Trials on ALK Grass tablet
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ALK-Abelló A/SCompleted
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Lars Olaf CardellCompletedAllergic Rhinitis Due to Grass PollenSweden
-
Karolinska InstitutetCompleted
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Aarhus University HospitalUniversity of Aarhus; University Hospital, LinkoepingActive, not recruitingAllergic Rhinitis Due to Grass Pollen | Allergic Asthma | Allergic Conjunctivitis of Both EyesDenmark, Sweden
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Karolinska InstitutetKarolinska University Hospital; Skane University Hospital; Sodra Alvsborgs HospitalCompletedRhinitis, AllergicSweden
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Lars Olaf CardellCompletedAllergic RhinitisSweden
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ALK-Abelló A/SCompleted