Randomized, open, single dose, cross-over study to validate a composite endpoint for acceptability evaluation of oral drug formulations in the paediatric populatio
- Conditions
- All paediatric patients who present to the Clinic for General Paediatrics, Neonatology and Paediatric Cardiology at the University Hospital Düsseldorf as outpatients or inpatients and who are able to swallow.
- Registration Number
- DRKS00027948
- Lead Sponsor
- Klinik für Allgemeine Pädiatrie, Neonatologie und Kinderkardiologie, Universitätsklinik Düsseldorf
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 320
Age: Children aged from 1 - <6 months and from 6 - <18 years
Sex: Male and female
Health: Participants suffering from illness must be able to swallow the oral formulations and to accept the study procedures. This conclusion is based on medical history, physical examination, and all other appropriate diagnostic procedures.
Compliance: Participants and participants’ parents understand and are willing, able, and likely to comply with examination procedures and restrictions.
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 study and have given written informed consent and assent where possible.
Disease/Illness: Any impairment of swallowing solids and liquids as a consequence of chronic illness (e.g. cerebral palsy), acute illness (e.g. sepsis, respiratory distress, gastroenteritis, respiratory tract infection), or oral deformation, as assessed by the investigator
Intolerance: Lactose intolerance
Pre- and Concomitant Medication: Any drug that causes nausea, fatigue, or palsy
Intervention: Children in the post-operative period who have yet to commence regular oral feeding
Nutrition: Children, who have eaten 1 hour before examination and who afterwards feel sick because of the food
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To validate a composite endpoint for acceptability evaluation (combination of palatability and deglutition scores) of 4 oral drug formulations in a paediatric population of different age groups that have so far not yet been investigated with the deglutition and palatability assessment method published by Klingmann et al.
- Secondary Outcome Measures
Name Time Method - To investigate the acceptability, swallowability and palatability of 3 mini-tablets in comparison to 1 mL glucose-syrup in children aged 1- <6 months<br>- To investigate the acceptability, swallowability, and palatability of 11 mini-tablets in comparison to 9 mL glucose-syrup, round tablets and oblong tablets in children aged 6 - <12 years<br>- To investigate the acceptability, swallowability and palatability of 70 mini-tablets in comparison to 18 mL glucose-syrup, round tablets, and oblong tablets in children aged 12 - <18 years<br>- To identify any possible problem that could occur during deglutition<br>- To identify the percentage of children who inhaled or coughed during ingestion of any of the oral placebo formulations<br>- To investigate the safety of the different formulations<br>