Trial document





This trial has been registered retrospectively.
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  DRKS00000432

Trial Description

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Title

Randomized, Cross-over Physiological Examination of Acceptability and Capability to Swallow Three Oral Placebo Formulations for Children of Six Different Age Groups

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Trial Acronym

[---]*

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URL of the Trial

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Brief Summary in Lay Language

This scientific examination explores whether children under the age of 6 years are capable to
swallow especially for children produced minitablets as good as syrup. Furthermore which one of
the oral fomulations is better accepted and which formulation is the best one for each age group.

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Brief Summary in Scientific Language

This Main Physiological Examination is aimed at generating reliable information on the
acceptability and the capability of children of different age groups to swallow oral placebo
formulations of different consistency to enable hypothesis generation for scientifically meaningful
evaluation of the acceptability and the capability of children of different age groups to swallow
different types of oral formulations.

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Organizational Data

  •   DRKS00000432
  •   2011/04/01
  •   [---]*
  •   yes
  •   Approved
  •   3495, 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

  •   Children not suffering from a special disease.
  •   [---]* -  [---]*
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Interventions/Observational Groups

  •   1 x 1 uncoated minitablet 2mm diameter per os
  •   1 x 1 coated minitablet 2mm diameter per os
  •   1 x 3ml glucose-syrup per os
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Basic research/physiological study
  •   Crossover
  •   I
  •   [---]*
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Primary Outcome

To prove that the acceptability of the uncoated minitablet is superior to the acceptability of the syrup in the group of children between 0.5 and 5 years inclusive.

These parameters are collected right after oral application by oral inspection.

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Secondary Outcome

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

To investigate the differences in the acceptability of the uncoated minitablet versus the syrup in each age group.

To investigate the differences in the acceptability of the coated minitablet versus the uncoated minitablet in each age group as well as for the whole population.

To investigate the differences in the acceptability of the coated minitablet versus the syrup in each age group as well as for the whole population.

To investigate the differences in the capability to swallow three different oral placebo formulations in each age group as well as in the whole population.

To identify the differences in percentage of children in the different age groups who choke on any of the three oral placebo formulations.

To identify the number of children who refuse to take an oral placebo formulation or who spit it out.

To identify any possible problem, that could occur during deglutition.

To show that children beginning at the age of six months are capable of swallowing a solid oral formulation.

To analyse the compliance of children requested to swallow a minitablet or glucose-syrup.

To identify the difference in palatability of the three oral placebo formulations.

To investigate the safety of all oral placebo formulations.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • [---]*
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Recruitment

  •   Actual
  •   2011/02/14
  •   306
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

1. Age: Children aged from 0.5 to 5 years inclusive
2. Sex: Male and female
3. Recruiting: Recruiting will take place in the Paediatric Clinic of University Hospital Düsseldorf
(inhouse and outpatient).
4. Health: Participants suffering from illness must be able to swallow in the opinion of the
Principal Investigator based on medical history, physical examination and all other appropriate
diagnostic procedures.
5. Compliance: Participant and participant's parents understand and are willing, able and like 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. gastroenteritis, respiratory tract infection)
c)oral deformation
2. Intolerance: Lactose-Intolerance
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 eat and
capable to follow the physiological examination-related instructions.
5. Nutrition: Children, who have eaten one hour before examination and who afterwards feel sick

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Universitätsklinik Düsseldorf Klinik für Allgemeine Pädiatrie
    • Mr.  PD Dr.  Thomas  Meissner 
    • Moorenstr 5
    • 40225  Düsseldorf
    • Germany
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    • Universitätsklinik Düsseldorf Klinik für Allgemeine Pädiatrie
    • Mr.  PD Dr.  Thomas  Meissner 
    • Moorenstr 5
    • 40225  Düsseldorf
    • Germany
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    • Universitätsklinik Düsseldorf Klinik für Allgemeine Pädiatrie
    • Mr.  PD Dr.  Thomas  Meissner 
    • Moorenstr 5
    • 40225  Düsseldorf
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinik Düsseldorf Klinik für Allgemeine Pädiatrie
    • Moorenstr. 5
    • 40225  Düsseldorf
    • Germany
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    •   [---]*
    •   [---]*
    •   [---]*
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Status

  •   Recruiting complete, follow-up complete
  •   2011/05/31
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.