Efficacy and Safety of 300 IR Sublingual Immunotherapy (SLIT) Tablets in Children Suffering From Grass Pollen Rhinoconjunctivitis

This study has been completed.
Sponsor:
Information provided by:
Stallergenes
ClinicalTrials.gov Identifier:
NCT00409409
First received: December 7, 2006
Last updated: September 28, 2011
Last verified: September 2011

December 7, 2006
September 28, 2011
December 2006
Not Provided
To assess the efficacy of SLIT for grass pollen allergens on the Rhinoconjunctivitis Total Symptom Score (RTSS) of the six rhinoconjunctivitis symptoms sneezing, rhinorrhoea, nasal pruritus, nasal congestion, ocular pruritus and watery eyes.
Same as current
Complete list of historical versions of study NCT00409409 on ClinicalTrials.gov Archive Site
To assess the efficacy of SLIT for grass pollen allergens on the rescue medication score and usage and to document the safety of the treatment.
Same as current
Not Provided
Not Provided
 
Efficacy and Safety of 300 IR Sublingual Immunotherapy (SLIT) Tablets in Children Suffering From Grass Pollen Rhinoconjunctivitis
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Allergy
Drug: Sublingual immunotherapy tablets of grass pollen allergen extract
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
280
August 2007
Not Provided

Inclusion Criteria:

  • Male or female outpatients aged 5 to 17 years.
  • Written consent / assent.
  • Grass pollen-related allergic rhinoconjunctivitis for at least the last two pollen seasons.
  • Sensitised to grass pollen (positive SPT and grass pollen-specific IgE values of at least Class 2).
  • Total symptom score on the Retrospective RTSS during the previous pollen season of greater than or equal to 12.

Exclusion Criteria:

  • Patients who have received any desensitisation treatment for grass pollen.
Both
5 Years to 17 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00409409
VO52.06
Not Provided
Not Provided
Stallergenes
Not Provided
Principal Investigator: Ulrich Wahn, Professor Charité - Campus Virchow Klinikum, Berlin, Germany
Stallergenes
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP