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

The acceptability of and preference among four oral dosage forms in infants and preschool children in the Netherlands: a randomised cross-over trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN63138435

Enrollment

150

Registered

2012-07-24

Start date

2011-01-01

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acceptability/preference of oral dosage forms Not Applicable

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
1. Child and parent acceptance 2. Child and parent preference	—

Secondary

Measure	Time frame
No secondary outcome measures	—

Countries

Netherlands

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 10, 2026