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Sponsored by: |
Stallergenes |
Information provided by: | Stallergenes |
ClinicalTrials.gov Identifier: | NCT00409409 |
A phase III study to evaluate the efficacy and safety of SLIT for grass pollen allergens compared with placebo for reduction of symptoms and rescue medication usage in children.
Condition | Intervention | Phase |
Allergy |
Drug: Sublingual immunotherapy tablets of grass pollen allergen extract |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomised, Double-Blind, Placebo-Controlled, Multi-National, Multi-Centre, Phase III Paediatric Study of the Efficacy and Safety of 300 IR Sublingual Immunotherapy (SLIT) Administered as Allergen-Based Tablets Once Daily to Children Suffering From Grass Pollen Rhinoconjunctivitis |
Estimated Enrollment: | 280 |
Study Start Date: | December 2006 |
Estimated Study Completion Date: | August 2007 |
Ages Eligible for Study: | 5 Years to 17 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Martine LE GALL | 00 1 55 59 25 56 | mlegall@stallergenes.fr |
Contact: Michel MELAC, MD | 00 1 55 59 25 28 | mmelac@stallergenes.fr |
Germany | |||||
Charité – Campus Virchow Klinikum | Recruiting | ||||
Berlin, Germany | |||||
Contact: Martine Legall |
Stallergenes |
Principal Investigator: | Ulrich Wahn, Professor | Charité – Campus Virchow Klinikum, Berlin, Germany |
Study ID Numbers: | VO52.06 |
First Received: | December 7, 2006 |
Last Updated: | December 7, 2006 |
ClinicalTrials.gov Identifier: | NCT00409409 |
Health Authority: | France: Afssaps - French Health Products Safety Agency; Spain: Spanish Agency of Medicines; Germany: Paul-Ehrlich-Institut; Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products; Denmark: Danish Medicines Agency |
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