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

This study has been completed.
Information provided by (Responsible Party):
ClinicalTrials.gov Identifier:
First received: December 7, 2006
Last updated: April 18, 2016
Last verified: April 2016
Results First Received: January 25, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Allergy
Interventions: Drug: 300 IR grass pollen allergen extract tablet
Drug: Placebo tablet

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
First Patient First Visit 16 DEC 2006, Last Patient Last Visit 12 SEP 2007

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
300 IR 300 IR grass pollen allergen extract tablet
Placebo Placebo tablet

Participant Flow:   Overall Study
    300 IR     Placebo  
STARTED     139     139  
COMPLETED     131     135  
NOT COMPLETED     8     4  
Adverse Event                 7                 2  
Withdrawal by Subject                 1                 1  
Any other reason not above-mentioned                 0                 1  

  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The Intent-to-treat (ITT) population included all patients who received at least one dose of the investigational product and had a Retrospective Rhinoconjunctivitis Total Symptom Score (RRTSS) and at least one Rhinoconjunctivitis Total Symptom Score (RTSS) during the pollen period while on treatment.

Reporting Groups
300 IR 300 IR grass pollen allergen extract tablet
Placebo Placebo tablet
Total Total of all reporting groups

Baseline Measures
    300 IR     Placebo     Total  
Number of Participants  
[units: participants]
  131     135     266  
[units: years]
Mean (Standard Deviation)
  10.5  (3.34)     11.2  (3.07)     10.9  (3.22)  
[units: participants]
Female     45     50     95  
Male     86     85     171  

  Outcome Measures

1.  Primary:   Average Rhinoconjunctivitis Total Symptom Score (ARTSS)   [ Time Frame: Pollen period (average of 38.6 days) ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact:  
Name/Title: Laurence Paolozzi, Medical Director
Organization: Stallergenes
phone: +33 (0) 1 55 59 26 33
e-mail: lpaolozzi@stallergenes.com

Publications of Results:

Responsible Party: Stallergenes
ClinicalTrials.gov Identifier: NCT00409409     History of Changes
Other Study ID Numbers: VO52.06
Study First Received: December 7, 2006
Results First Received: January 25, 2016
Last Updated: April 18, 2016
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
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