All patients taking oral furosemide and meeting the inclusion and exclusion criteria will be considered. Other
Conditions
Interventions
This study investigates a single replacement dose exposure of an orodispersible tablet formulation of furosemide (dose given as per current prescription).
The clinical team will identify participants
Sponsors
Proveca (United Kingdom)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Participants aged from birth (including pre-term neonates) to less than 12 years old (i.e up to their 12th birthday). 2. No limitation of nationalities, demographics, socio-economic or ethnic groups. 3. Written informed consent must be obtained from the child’s parent / carer with parental responsibility. 4. Consent needs to be sought from a legal guardian who has an appropriate understanding of written English. If this is not possible, an interpreter will be sought. Parents/carers must however have the capacity to be able to understand the study information. 5. Written assent will be sought for all study participants aged 6 years and over, where appropriate. Ability to assent will be judged on a case-by-case basis by the research team. 6. The participant (inpatient or outpatient) is currently taking an oral formulation of furosemide and has completed at least 48 hours of oral treatment, with no dose alterations planned. 7. The participant (in agreement with their legal guardian) is willing to be video recorded while the study medication is administered. 8. The clinical team and/or the participant’s parent / carer raise no concerns about the child’s involvement in this study.
Exclusion criteria
Exclusion criteria: 1. Participants aged 12 years and older. 2. Participant(s) whose parent/guardian is unable to read and/or understand the study information sheet provided. 3. Child participant refuses to provide verbal assent to take part in the study, where appropriate. 4. Parent/carer unable or unwilling to give informed consent. 5. The participant has a known swallowing difficulty (with either solid or liquids). 6. The treating clinical team feel the participants’ current prescribed dose of furosemide may need to change imminently i.e. their furosemide dose is too unstable/variable at present. 7. Participant is receiving their dose of oral furosemide via any type of enteral feeding tube such as nasogastric (NG) tube or percutaneous endoscopic gastrostomy (PEG). 8. The child has a known allergy (or intolerance) to furosemide or any of the excipients included within the new ODT furosemide formulation. 9. The treating clinical team feel there are family or social issues (e.g. pronounced family distress or child protection intervention) that would make it inappropriate to approach the family to take part in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Acceptability is measured with an adapted version of the composite endpoint using a score for swallowability at the time the participant takes the furosemide and a score for palatability performed by two researchers reviewing the videos that were taken of the participant taking the replacement dose | — |
Secondary
| Measure | Time frame |
|---|---|
| The number of participants willing to take the orodispersible tablet formulation of furosemide in the future was measured using the following questions in participant or parent/carer questionnaires after the dose is given: Overall, how happy would you be to take this new medicine in the future? Would you be happy to give your child this new medicine in the future? | — |
Countries
England, United Kingdom
Contacts
Public ContactMaisie Stephenson
Outcome results
None listed