Trial document




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  DRKS00003698

Trial Description

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Title

Swallowing problems - empirical evaluation of the swallowability of solid oral drugs (part 2)

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

About one quarter of patients suffer from difficulties in swallowing tablets and capsules. This study aims to evaluate two factors that may influence the ability to swallow tablets and capsules: the density of tablets and capsules and the head position during swallowing. Three different dosage forms have to be swallowed in two different head positions. The results should help to identify, develop and prescribe dosage forms which are easier to swallow.

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Brief Summary in Scientific Language

About one quarter of the general practitioners’ population suffers from difficulties in swallowing solid oral dosage forms. Affected patients tend to modify their drugs. However, modifications can have serious consequences, such as overdosage or inactivation of drugs, which is often accompanied by a loss of efficacy. Despite this awareness only few studies have been conducted which addressed the influence of the dosage form (e.g. size, shape, height) on swallowability. This study aims to investigate, whether the drugs’ density and head posture during swallowing influence the swallowability of solid oral dosage forms. Three different dosage forms have to be swallowed in two different head positions. The study results should help to identify, develop and prescribe dosage forms which are easier to swallow.

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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

  •   DRKS00003698
  •   2012/04/17
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  •   yes
  •   Approved
  •   S-278/2011, Ethik-Kommission I der Medizinischen Fakultät Heidelberg
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Secondary IDs

  •   DRKS00003243  (DRKS-ID Studienteil/study part 1)
  •   DRKS00003709  (DRKS-ID Studienteil/study part 3)
  •   DRKS00004174  (DRKS-ID Studienteil/study part 3)
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Health Condition or Problem studied

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

  •   At several wards of the University Hospital of Heidelberg consecutive inpatients will be included in the study. After informed consent the patients will be asked to swallow 3 different placebo dosage forms twice. Once they have to swallow with an arbitrary head posture and once with a specified head posture (random order). After swallowing each placebo the swallowability will be evaluated by the patients with a standardized questionnaire. After the evaluation of all placebos is completed the participants will be asked to rank the placebos by sight, from easiest to most difficult to swallow.
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Basic research/physiological study
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

1. Identification of the dosage form which is easiest to swallow (overall, affected and non-affected patients) (Scale 0-7, 0=very easy, 7 very hard to swallow).
2. Improvement of the swallowability due to the intervention (variation of head posture)

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Secondary Outcome

1. Comparison of visual ranking and ranking after swallowing

2. Association of BMI and height with the ability to swallow oral dosage forms

3. Association of age and gender with the ability to swallow oral dosage forms

4. Association of diseases and amount of drugs with the ability to swallow oral dosage forms

5. Association of preferred dosage forms and tablet shapes with the ability to swallow oral dosage forms and the results of visual ranking


6. In order to differentiate swallowability of the different dosage forms in more detail the following observations are compared:
- Frequency with which placebos could not be swallowed

- Average number of swallows needed to swallow the placebos

- Average amount of water needed to swallow the placebos

- Frequency with which placebos are felt or get stuck in the throat/esophagus

- Frequency of choking due to swallowing the placebos

- Frequency of required changes of the placebos according to a better swallowability

- Frequency and kind of required changes

7. Frequency of possible dosage form substitutions within ATC-Codes to prescribe dosage forms which are easier to swallow according to the study results

8. Frequency of possible aut simile substitutions to prescribe dosage forms which are easier to swallow according to the study results

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2012/04/17
  •   125
  •   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 years old
2. Inpatients of the University Hospital of Heidelberg
3. Patients who are allowed to swallow placebos after being assessed by the physician
4. Patients have to be positioned upright

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Exclusion Criteria

1. ≤ 18 years old
2. Patients suffering from dysphagia
3. Patients who are not allowed to swallow placebos due to other diseases/medical conditions/tests after being assessed by the physician
4. Insufficient German language skills
5. Insufficient cognitive skills

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Addresses

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    • 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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    • 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 ongoing
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Trial Publications, Results and other Documents

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