Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00011459

Trial Description

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Title

An Observational Study of ORALAIR® (Grass Pollen Allergen Extract From: Cocksfoot, Sweet Vernal, Rye Grass, Meadow Grass, Timothy) Tablet for Sublingual Use in Children 5 to 9 Years of Age With Grass-pollen-induced Allergic Rhinitis With or Without Conjunctivitis

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Safety and tolerability of ORALAIR in children 5 to 9 years of age during the first 30 days
of treatment.

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Brief Summary in Scientific Language

The purpose of this study is to further describe the safety and tolerability of ORALAIR
tablets in children 5 to 9 years of age with grass-pollen-induced allergic rhinitis with or
without conjunctivitis.

Patients are followed for safety and tolerability during the first 30 treatment days.

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Organizational Data

  •   DRKS00011459
  •   2017/05/08
  •   2014/11/18
  •   no
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Secondary IDs

  •   NCT02295969  (ClinicalTrials.gov)
  •   SL74.14  (Stallergenes)
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Health Condition or Problem studied

  •   Allergy
  •   J30.4 -  Allergic rhinitis, unspecified
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Interventions/Observational Groups

  •   Drug: Oralair
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Characteristics

  •   Non-interventional
  •   Observational study
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  •   N/A
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Primary Outcome

- All adverse events that started on or after the day the first dose of Oralair; time frame: During 30 days after the date of the first dose

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Secondary Outcome

[---]*

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  •  
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Recruitment

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  •   2014/12/31
  •   300
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   5   Years
  •   9   Years
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Additional Inclusion Criteria

Allergen immunotherapy naive male or female outpatients aged 5 to 9 years (inclusive)
prescribed ORALAIR.

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Exclusion Criteria

Patients already participating in a clinical trial.

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Addresses

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    • Stallergenes
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    • Venn Life Sciences
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  • start of 1:1-Block address scientific-contact
    • Agnès VIATTE 
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    • Agnès VIATTE 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   1
  •   2016/12/12
* This entry means the parameter is not applicable or has not been set.