The present study investigates whether the appearance of a drug can have a potential impact on its acceptability by the patients.
Conditions
Interventions
Group 1: Children aged 6-<12 y:
Round tablet: ø 6 mm
Oblong tablet: 6 x 2.5 mm
Mini-tablets (2 mm): 11 mini-tablets
Granules: Half teaspoon
Group 2: Adolescents aged 12-<18 y:
Round tablet: ø 13 mm
Ob
Sponsors
Universitätsklinikum Düsseldorf
Eligibility
Sex/Gender
All
Age
6 Years to 17 Years
Inclusion criteria
Inclusion criteria: -Age: Children aged 6-<12 y Adolescents aged 12 - <18 y -Sex: Male or female (balanced) -Disease and severity: Chronically or acutely ill -Previous therapy: Not applicable -Other specific requirements: Children/adolescents are able to understand questions and procedures The children/adolescents’ health status must in general enable them to swallow and understand the need for taking a medication orally Willingness and capability of participants to comply with the examination procedures - Informed consent: Informed consent from at least from one parent or legal representative and assent from the participants. Both documented with a checked box ("click-to-agree") in the eCRF.
Exclusion criteria
Exclusion criteria: - Disease/illness: Colour blindness
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoints are defined as: - Percentage of participants who ranked a specific colour on 1st, 2nd or 3rd place -Preference with regard to colour for the following formulations: (i) a round tablet, (ii) an oblong tablet, (iii) mini-tablets, and (iv) granules, as assessed by a 5-point Likert scale and a ranking (1-3) -Extent of preference of (i) a round tablet, (ii) an oblong tablet and (iii) mini-tablets in white colour in comparison to the selected preferred colour, as assessed by a 5-point Likert scale -Preference in taking (i) a round tablet or (ii) an oblong tablet with or without embossing as assessed by a 3-point scale -Extent of preference for taking a non-embossed white (i) round tablet or (ii) oblong tablet compared to (i) a round tablet or (ii) an oblong tablet with the preferred colour and embossing type (with or without embossing), as assessed by a 5-point Likert scale | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoints are defined as: -Willingness to take (i) a round tablet, (ii) an oblong tablet, (iii) mini-tablets, and (iv) granules, as assessed by a 5-point Likert scale -Willingness to take a (i) round tablet, (ii) an oblong tablet, and (iii) mini-tablets in all 6 selectable colours as assessed by a 5-point Likert scale | — |
Countries
Germany
Contacts
Public ContactViviane Klingmann
Klinik für Allgemeine Pädiatrie, Neonatologie und Kinderkardiologie
Outcome results
None listed