Manipulation and Administration of Generic and Innovative Child patient medicines - CLINical STUDy: the acceptability of and preference among four oral dosage forms in infants and preschool children in the Netherlands
| ISRCTN | ISRCTN63138435 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN63138435 |
| Secondary identifying numbers | MAGIC CLINSTUD |
- Submission date
- 23/06/2012
- Registration date
- 24/07/2012
- Last edited
- 29/09/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and study aims
It can be difficult to give medicines to young children. Children may not want to take them or spit them out. However, it is very important that children swallow the full dose of a medicine. There is some evidence that the problems giving oral liquid medicines such as suspensions and syrups to young children are more profound than the problems giving oral solid flexible preparations such as powders and minitablets. Nevertheless a lot of medicines for young children are only commercially available in their liquid form. We want to study whether this approach is correct or in need of change.
Who can participate?
Parents of children aged 1 to 4 years.
What does the study involve?
Parents will be asked to administer four oral dosage forms to their child. Each dosage form should be given twice on one day. Parents will be asked to fill in a participant diary. The first domain should be filled in prior to the study. It includes questions about child and family characteristics . The second domain includes questions for each of the eight administrations as to whether the dosage form has been given, the method of administration, the childs acceptance and the result of the intake. The third domain should be filled in at the end of the study. Parents will be asked to indicate child and parent preference plus additional comments.
What are the possible benefits and risks of participating?
The risks to the participants are considered negligible. All four dosage forms are commonly used in the Netherlands in children. The parents may refrain from administration whenever they consider this necessary, such as when they are afraid to give the mini-tablet to their child because they think the child cannot swallow it. Parents should stop offering the dosage form when the child does not want to take it. The dosage forms do not include an active substance i.e. they are placebo (dummy) medicine and this is known to the parents. Parents may explain the study purposes to their child when they consider this necessary (e.g., when the child does not understand why he has to take a medicine when he is not ill). Participating children and their parents may benefit from the study outcomes as soon as the results have been implemented and they (or their children) are in need of a real medicine. The anticipated benefits to children and their parents as a group are the availability of dosage forms that are better tailored to their needs
Where is the study run from?
The dosage forms should be administered by the parents as part of normal family routines. Thus the medicines will mostly be given at home; however, administration at other locations (e.g., when visiting grandparents etc) is also accepted.
When is the study starting and how long is it expected to run for?
The patients will be recruited in 2011 and the dosage forms should be used within their shelf-life.
Who is funding the study?
The study will be funded by two separate agencies of the Ministry of Health, Welfare and Sports in the Netherlands, namely the RIVM and the MEB. The study will be conducted in cooperation with Utrecht University and the STMR.
Who is the main contact?
Diana van Riet-Nales
Contact information
Scientific
Graadt van Roggenweg 500
Utrecht
3503 RG
Netherlands
Study information
| Study design | Randomised cross-over clinical trial for the type of the dosage form |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Other |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | The acceptability of and preference among four oral dosage forms in infants and preschool children in the Netherlands: a randomised cross-over trial |
| Study acronym | MAGIC CLINSTUD |
| Study objectives | The objective of this study is threefold: 1. To investigate the child and parent acceptance of four oral dosage forms in outpatient infants and preschool children (age 1-4 years) in the Netherlands. The dosage forms include a placebo 4-mm tablet, powder, syrup and suspension, all aimed at a neutral taste. 2. To investigate the child's and parents' preference of these dosage forms at the end of the study. 3. To investigate the impact of the child and family characteristics on the outcomes for the child and parent acceptance and preference. The data that will be collected to enable the aforementioned three aims to be answered (e.g., how parents are administering a specific dosage form to their child when given the instruction twice daily only) may also be evaluated on their own. |
| Ethics approval(s) | Ethical approval was waived by the Central Committee on Research involving human subjects (CCMO) on the basis of the Medical Research Involving Human Subjects Act (WMO) in the Netherlands. Hence, approval was obtained from the Institutional Review Board of the Utrecht Institute for Pharmaceutical Sciences (UIPS). The investigator has sent an inquiry to the CCMO as to whether this trial falls under the range of the WMO and hence, whether it would be subject to medical approval. |
| Health condition(s) or problem(s) studied | Acceptability/preference of oral dosage forms |
| Intervention | The intervention will consist of the request to parents to administer four oral dosage forms to their child during normal family routines. Each dosage form should be given twice on one day in the same way the parents should administer a prescribed medicine, but without any physical or psychological compulsion. Details of Joint Sponsor: Medicines Evaluation Board in the Netherlands c/o Christine Gispen Graadt van Roggenweg 500 P.O. Box 8275, 3503 RG Utrecht The Netherlands Email: cc.gispen@cbg-meb.nl Tel: + 31 (0) 88 224 8081 |
| Intervention type | Other |
| Primary outcome measure | 1. Child and parent acceptance 2. Child and parent preference |
| Secondary outcome measures | No secondary outcome measures |
| Overall study start date | 01/01/2011 |
| Completion date | 31/12/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 1 Year |
| Upper age limit | 4 Years |
| Sex | Both |
| Target number of participants | 150 |
| Key inclusion criteria | Children will be eligible for inclusion in this study if aged 1-4 years and if their parents have mastery of the Dutch language |
| Key exclusion criteria | 1. Mentally disabled 2. Having a condition that might have an impact on medication intake or requiring oral medication 3. Hypersensitivity to lactose, having cow's milk allergy or having an allergy of unknown origin 4. A member of staff of the preventive healthcare clinic considered that study participation was inappropriate in view of the family situation |
| Date of first enrolment | 01/01/2011 |
| Date of final enrolment | 31/12/2011 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
3503 RG
Netherlands
Sponsor information
University/education
c/o Prof. Dr. A.C.G. Egberts
Faculty of Science
Utrecht Institute for Pharmaceutical Sciences
Division Pharmacoepidemiology & Clinical Pharmacology
PO Box 80 082
Utrecht
3508 TB
Netherlands
| Website | http://www.uu.nl/Nl/Pages/default.aspx |
|---|---|
"ROR" |
https://ror.org/04pp8hn57 |
Funders
Funder type
Government
No information available
Government organisation / National government
- Alternative name(s)
- Medicines Evaluation Board, CBG
- Location
- Netherlands
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/09/2013 | Yes | No |
