Trial document




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  DRKS00003243

Trial Description

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Title

Swallowing problems - empirical evaluation of the swallowability of solid oral drugs (part 1)

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Trial Acronym

K306

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URL of the Trial

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Brief Summary in Lay Language

Pilot Study
One quarter of the general practitioners’ population complains about difficulties with swallowing solid oral dosage forms. People, who are facing such problems, tend to modify their medications. Modifications can have serious consequences, such as overdosage or inactivation of drugs, which can be accompanied by a loss of efficacy. Despite this awareness, there are no studies which have assessed the influence of dosage form (tablet vs capsule), their size, shape and other factors such as height on the swallowability. This study aims to investigate, if these factors have a clinical relevant influence on the swallowability of solid oral dosage forms. For this purpose, all patients who take part, are asked to swallow 4 different placebo dosage forms and to evaluate their swallowability.The results will allow to identify and prescribe the most comfortable dosage forms.

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Brief Summary in Scientific Language

Pilot Study
One quarter of the general practitioners’ population complains about difficulties with swallowing solid oral dosage forms. People, who are facing such problems, tend to modify their medications. Modifications can have serious consequences, such as overdosage or inactivation of drugs, which is accompanied by a loss of efficacy. Despite this awareness, there are no studies which have assessed the influence of dosage form, their size, shape and other factors such as height on the swallowability. This study aims to investigate, if these factors have a clinical relevant influence on the swallowability of solid oral dosage forms. The results will allow to identify and prescribe the most comfortable dosage forms.

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00003243
  •   2011/09/01
  •   [---]*
  •   yes
  •   Approved
  •   S-278/2011, Ethik-Kommission I der Medizinischen Fakultät Heidelberg
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Secondary IDs

  •   DRKS00003698   (DRKS-ID Studienteil/study part 2)
  •   DRKS00003709  (DRKS-ID Studienteil/study part 3)
  •   DRKS00004174  (DRKS-ID Studienteil/study part 4)
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Health Condition or Problem studied

  •   R13.9 -  [generalization R13: Dysphagia]
  •   [---]* -  [---]*
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Interventions/Observational Groups

  •   All consecutive inpatients of several wards will be informed about this study. After informed consent they are asked to swallow 4 different placebo dosage forms and to evaluate their swallowability.
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Other
  •   Single (group)
  •   N/A
  •   [---]*
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Primary Outcome

Identify the easiest to swallow dosage form on the basis of the evaluation of the participating patients.

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Secondary Outcome

1. Order of the serverity of swallowing in comparison to the order if ranked visually.
2. Differentiated evaluation of the swallowability of the different dosage forms (e.g. needed amount of water, frequency of placebos being felt in the throat during swallowing, frequency of desired changes of the swallowed dosage forms)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • [---]*
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Recruitment

  •   Actual
  •   2011/09/05
  •   80
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

1. ≥ 18
2. Inpatients

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Exclusion Criteria

1. Dysphagia
2. Patients who cannot be positioned upright
3. Patients who are not awake and responsive

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Universitätsklinikum Heidelberg
    • Mr.  Prof. Dr. med.  Walter Emil  Haefeli 
    • Im Neuenheimer Feld 410
    • 69120  Heidelberg
    • Germany
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    • Universitätsklinikum Heidelberg
    • Ms.  Julia   Schiele 
    • Im Neuenheimer Feld 410
    • 69120  Heidelberg
    • Germany
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    end of 1:1-Block address contact scientific-contact
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    • Universitätsklinikum Heidelberg
    • Ms.  Julia   Schiele 
    • Im Neuenheimer Feld 410
    • 69120  Heidelberg
    • Germany
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Sources of Monetary or Material Support

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    • Deutsche Forschungsgemeinschaft
    • Kennedyallee 40
    • 53175  Bonn
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2011/09/17
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Trial Publications, Results and other Documents

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