Tolerability of ALK Grass Tablet in Children
Sponsor
ALK-Abelló A/S (Industry)
Overall Status
Completed
CT.gov ID
NCT00310453
Collaborator
(none)
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Study Details
Study Description
Brief Summary
The purpose of this trial is to assess whether the ALK Grass tablet treatment is safe to use in children aged 5-12 years
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double
Official Title:
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)
Study Start Date
:
Mar 1, 2006
Study Completion Date
:
May 1, 2006
Outcome Measures
Primary Outcome Measures
- Assessment of safety by recording of adverse events []
Eligibility Criteria
Criteria
Ages Eligible for Study:
5 Years
to 12 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Servicio de Alergia, Hospital del Niño Jesús | Madrid | Spain | 28040 |
Sponsors and Collaborators
- ALK-Abelló A/S
Investigators
- Study Director: Kim Simonsen, MD, ALK-Abelló A/S, Boege Alle 6-8, 2970 Hoersholm, Denmark
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00310453
Other Study ID Numbers:
- GT-09
First Posted:
Apr 4, 2006
Last Update Posted:
May 4, 2006
Last Verified:
May 1, 2006