Trial document




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  DRKS00008843

Trial Description

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Title

A Randomized, Single-dose, Cross-over Study to Investigate the Suitability of Multiple Placebo Mini-tablet Administration in Small Children

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

It is important to demonstrate that a large number of uncoated mini-tablets can be administered to small children to achieve the application of higher doses of different medications with this dosage form, and therefore the investigation of suitability of multiple mini-tablets per application is necessary. The goal of this study is to find out, how many whether 25, 100 or 400 uncoated mini-tablets are acceptable and swallowed by the children of the respective age groups.

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Brief Summary in Scientific Language

A Randomized, Single-dose, Cross-over Study wit 372 patients in two Age Groups to Investigate the Suitability of Multiple Placebo Mini-tablet Administration (Age Group 1: 25 and 100 mini-tablets, Age Group 2: 100 and 400 mini-tablets) in Small Children aged 6 months to 5 years inclusive.

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Organizational Data

  •   DRKS00008843
  •   2015/06/29
  •   2015/03/06
  •   yes
  •   Approved
  •   5044R, Ethik-Kommission an der Medizinischen Fakultät der Heinrich-Heine-Universität Düsseldorf
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Secondary IDs

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Health Condition or Problem studied

  •   No specific disease. Placebo Administration to hospitalised patients.
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Interventions/Observational Groups

  •   Each patient is assigned to one of the two age groups depending on the age. The sequence of the three administrations (lower number of placebo mini-tablets, higher number of placebo mini-tablets and glucose sirup) is randomised.


    Patients of age group 1 (0,5-1 year inclusive) receive 25 placebo mini-tablets that shoud be swallowed with a soft food or a drink.


    Patients of age group 2 (2-5 years inclusive) receive 100 placebo mini-tablets that shoud be swallowed with a soft food or a drink.
  •   Patients of age group 1 (0,5-1 year inclusive) receive 100 placebo mini-tablets that shoud be swallowed with a soft food or a drink.


    Patients of age group 2 (2-5 years inclusive) receive 400 placebo mini-tablets that shoud be swallowed with a soft food or a drink.
  •   Patients of age group 1 (0,5-1 year inclusive) receive 5 ml of glucose sirup that shoud be swallowed without any soft food or drink.


    Patients of age group 2 (2-5 years inclusive) receive 10 ml Glucose sirup that shoud be swallowed without any soft food or drink.
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Other
  •   Other
  •   Crossover
  •   N/A
  •   N/A
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Primary Outcome

To demonstrate non-inferiority in suitability of 25 uncoated mini-tablets administered at a time in comparison to 5 ml glucose syrup in children between 6 months and 1 year inclusive.

This outcome will be determined after one administration of mini-tablets and one administration of sirup and will be evaluated with predefined evaluationcriteria at the bedside.

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Secondary Outcome

To demonstrate non-inferiority in suitability of 100 uncoated mini-tablets administered at a time in comparison to 5 ml glucose syrup in children between 6 months and 1year inclusive.

To demonstrate non-inferiority in suitability of 100 uncoated mini-tablets administered at a time in comparison to 10 ml glucose syrup in children between 2 and 5 years inclusive.

To demonstrate non-inferiority in suitability of 400 uncoated mini-tablets administered at a time in comparison to 10 ml glucose syrup in children between 2 and 5 years inclusive.

To compare the capability of children between 6 months and 1 year inclusive to swallow 25 and 100 uncoated mini-tablets in comparison to 5 ml syrup.

To compare the capability of children between between 2 and 5 years inclusive to swallow100 and 400 uncoated mini-tablets in comparison to 10 ml syrup.

To identify the number of mini-tablets that young children are able to swallow.

To identify the number of mini-tablets that young children are able to accept.

To investigate the differences in the deglutition of multiple uncoated mini-tablets and syrup.

To investigate the differences in the suitability of multiple uncoated mini-tablet versus the syrup.

To prove that small children are able to swallow multiple solid formulation as well as a liquid.

To identify any possible problem that could occur during deglutition.

To identify the percentage of children who inhaled or coughed during ingestion of any of the oral placebo formulations.

To investigate the safety of the oral placebo formulations.

To identify the percentage of approached parents willing to participate in this study.

To identify reasons why approached parents are not willing to participate in this study.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2015/06/30
  •   372
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   6   Months
  •   6   Years
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Additional Inclusion Criteria

1. Age
Children aged from 6 months to 5 years inclusive

2. Sex
Male or female

3. Recruitment
Recruiting will take place in the Paediatric Clinic of the University Hospital Düsseldorf, Germany (in-house patients and outpatients).

4. Health
Children are under diagnostic procedures and/or treatment. Based on medical history, physical examination and all other appropriate diagnostic procedures they are able to swallow the three formulations and to accept the study procedures.

5. Compliance
Participant and participant’s parents understand and are willing, able and likely to comply with examination procedures and restrictions.

6. Consent
Participant and/or participant’s parents are capable of understanding the examination procedures, participant obligations as well as risks and benefits of participation in this physiological examination and have given written informed consent.

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Exclusion Criteria

1. Disease/Illness
Any impairment of swallowing either solids or glucose-syrup as a consequence of
a) chronic illness (e.g. cerebral palsy)
b) acute illness (e.g. sepsis, respiratory distress, gastroenteritis, respiratory tract infection)
c) oral deformation

2. Intolerance
Lactose-Intolerance in family history

3. Pre- and Concomitant Medication
Any drug that causes nausea, fatigue or palsy

4. Intervention
No examination shortly after surgical intervention until child is allowed to drink

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Addresses

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    • Klinik für Allgemeine Pädiatrie, Neonatologie und Kinderkardiologie, Universitätsklinik Düsseldorf
    • Moorenstr. 5
    • 40225  Düsseldorf
    • Germany
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    • Klinik für Allgemeine Pädiatrie, Neonatologie und Kinderkardiologie
    • Mr.  Dr  Hans Martin  Bosse 
    • Moorenstr. 5
    • 40225  Düsseldorf
    • Germany
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    • Klinik für Allgemeine Pädiatrie, Neonatologie und Kinderkardiologie, Universitätsklinik Düsseldorf
    • Mr.  Dr. med  Hans Martin  Bosse 
    • Moorenstr. 5
    • 40225  Düsseldorf
    • Germany
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Sources of Monetary or Material Support

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    • Klinik für Allgemeine Pädiatrie, Neonatologie und Kinderkardiologie
    • Moorenstr. 5
    • 40225  Düsseldorf
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2016/01/18
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Trial Publications, Results and other Documents

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