Randomized, open-label, single dosing, cross-over study to investigate the acceptability, swallowability and palatability of multiple coated drug-free minitablets in young childre
- Conditions
- As this is a placebo study, children with any condition can be included.
- Registration Number
- DRKS00027631
- 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
1. Children aged from 1 month to 6 years inclusive
Sex
2. Male and female
Health
3. Based on medical history, physical examination, and all other appropriate diagnostic procedures they are able to swallow. Participants suffering from illness must be able to swallow the mini-tablets and to accept the study procedures. This conclusion is based on medical history, physical examination, and all other appropriate diagnostic procedures as assessed by the Principal Investigator, Principal Investigator’s deputies, or sub-investigators.
Compliance
4. Participants and participants’ parents understand and are willing, able, and likely to comply with examination procedures and restrictions.
Consent
5. Participant and/or participant’s parents or legal guardians 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
1. Any impairment of swallowing solids 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
2. Lactose-Intolerance
Pre- and Concomitant Medication
3. Any drug that causes nausea, fatigue, or palsy
Intervention
4. Children in the post-operative period who have yet to commence regular oral feeding
Nutrition
5. Children, who have eaten one 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 The primary objective of this study is to investigate the acceptability of a high quantity of 2 mm diameter coated mini-tablets compared to a low quantity of 2.5 mm diameter coated mini-tablets of in children aged from 1 month to 6 years accounting for the requirement of weight based dosing in different age groups.
- Secondary Outcome Measures
Name Time Method - To compare the swallowability of 2 mm and 2.5 mm mini-tablets in children aged from 1 month to 6 years<br>- To compare the palatability of 2 mm and 2.5 mm mini-tablets in children aged from 1 month to 6 years<br>- To identify any possible problem that could occur during swallowing<br>- To identify the percentage of children who inhaled or coughed during ingestion of any of the oral formulations<br>- To investigate the safety of the drug-free mini-tablets