ICTRP Search Portal

Main

Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	German Clinical Trials Register
Last refreshed on:	8 April 2024
Main ID:	DRKS00003243
Date of registration:	01/09/2011
Prospective Registration:	Yes
Primary sponsor:	Universitätsklinikum Heidelberg
Public title:	Swallowing problems - empirical evaluation of the swallowability of solid oral drugs (part 1)
Scientific title:	Swallowing problems - empirical evaluation of the swallowability of solid oral drugs (part 1) - K306
Date of first enrolment:	05/09/2011
Target sample size:	80
Recruitment status:	Complete
URL:	http://drks.de/search/en/trial/DRKS00003243
Study type:	interventional
Study design:	Allocation: N/A: single arm study; Masking: Open (masking not used); Control: uncontrolled; Assignment: single; Study design purpose: other
Phase:	N/A

Countries of recruitment
Germany

Contacts

Name:	Julia Schiele
Address:	Im Neuenheimer Feld 410 69120 Heidelberg Germany
Telephone:	06221/56-37113
Email:	julia.schiele@med.uni-heidelberg.de
Affiliation:	Universitätsklinikum Heidelberg

Name:	Julia Schiele
Address:	Im Neuenheimer Feld 410 69120 Heidelberg Germany
Telephone:	06221/56-37113
Email:	julia.schiele@med.uni-heidelberg.de
Affiliation:	Universitätsklinikum Heidelberg

Key inclusion & exclusion criteria

Inclusion criteria: 1. = 18
2. Inpatients
Exclusion criteria: 1. Dysphagia
2. Patients who cannot be positioned upright
3. Patients who are not awake and responsive

Age minimum: 18 Years
Age maximum: None
Gender: All

Health Condition(s) or Problem(s) studied

R13.9

Intervention(s)

Group 1: 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.

Primary Outcome(s)

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

Secondary Outcome(s)

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)

Secondary ID(s)

Source(s) of Monetary Support

Deutsche Forschungsgemeinschaft

Secondary Sponsor(s)

Ethics review

Status: Approved
Approval date: 13/07/2011
Contact:

ethikkommission-I@med.uni-heidelberg.de

Ethikkommission der Medizinischen Fakultät Heidelberg

+49-6221-338220

ethikkommission-I@med.uni-heidelberg.de

Results

Results available:
Date Posted:
Date Completed:	17/09/2011
URL:	http://drks.de/search/en/trial/DRKS00003243#studyResults

Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.