HealthyNCT03581799
Palatability of an Oral Dispersible Tablet (ODT) Formulation in Children
A study testing Oral dispersible tablet in people with Healthy, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
This is a cross-sectional study investigating the palatability of an oral dispersible tablet with no pharmacologically active agent (carrier tablet) in children without underlying acute or chronic disease aged 2 to 10 years of age. Read more about this study
- Who is it for?
- Ages 2 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Oral dispersible tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSwitzerland
- Study dates
- 29 Jan 2018to 12 Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age between 2 and 10 years
- Attending study site as an outpatient during the study period.
- Informed consent form for study participation signed by legal guardian
- Verbal assent to participation from child
Who cannot join
- Wearing dental braces
- Injuries or inflammatory disease affecting the oral cavity or throat
- Dysphagia
- Olfactory impairment
- Known renal impairment
- Known hypercalcaemia,
Show all 12Show fewer
- Any known allergy against medications
- Ongoing antibiotic treatment at the time of the study
- Moderate-severe developmental delay as reported by the parents
- Parents/legal guardians are unlikely to reliably complete structured questionnaire because of significant language barriers
- Participation in another study with investigational drug within the 30 days preceding and during the present study,
- Previous enrolment into the current study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of Palatability of an Oral Dispersible Tablet (ODT) Formulation in Children Aged 2 to 10 Years
This is a cross-sectional study investigating the palatability of an oral dispersible tablet with no pharmacologically active agent (carrier tablet) in children without underlying acute or chronic disease aged 2 to 10 years of age.
Read the detailed description
Oral dispersible tablets (ODTs) are a monolithic solid formulation potentially appropriate for a wide range of paediatric age groups. They also have a number of advantages over more frequently used formulation types, such as suspensions. Currently few Commercial products are available as ODTs for administration to children. Investigators aimed to investigate the palatability of an oral dispersible tablet with no pharmacologically active agent (carrier tablet) by assessing overall parent-reported, observer-reported and, where appropriate, child-reported acceptance of the formulation. In addition, investigators assessed the in situ disintegration behaviour of the carrier tablet.
- Conditions
- Healthy
- Being tested
- Oral dispersible tablet
- Keywords
- Child
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral dispersible tabletOther
Also called Oral dispersible tablet (carrier tablet - no active pharmacological ingredient)
Administration of a 5 mm calcium carbonate based ODT placed in the buccal pouch (children aged 2-5 years) or on the tongue (children aged 6-10 years).
| Study group | Role | What they receive |
|---|---|---|
| Oral dispersible tablet | Other | 5 mm calcium carbonate based ODT will be administered by placing it in the buccal pouch (children aged 2-5 years) or on the tongue (children aged 6-10 years). Receives: Other: Oral dispersible tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parent-reported palatability assessed by interview
5-point Likert scale, 1 "completely acceptable" to 5 "completely unacceptable"
Measured: Day 1
Child-reported palatability (children aged 6-10 years only) assessed by interview
6-point Facial Hedonic Scale (0 "no discomfort on taking tablet" to 10 "maximum discomfort on taking tablet"
Measured: Day 1
Secondary outcomes (2)
Observer-reported palatability assessed by questionnaire
4-point Likert scale (0 "child refuses to take tablet" to 4 "child proactively takes tablet")
Measured: Day 1
In-situ disintegration behaviour of carrier tablet
Staff-observed disintegration of the tablet at 20, 40 and 60 seconds of placement
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2018
- Study start29 Jan 2018
- Primary completion12 Mar 2018
- Study completion12 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julia Bielicki, MD, Principal investigator, University of Basel Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03581799
- Sponsor's protocol ID
- 2017-01367
- Other IDs
- 2017
- Status last verified
- Jul 2018
- First submitted
- 21 Jun 2018
- Last updated
- 12 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Palatability of an Oral Dispersible Tablet (ODT) Formulation in Children Aged 2 to 10 Years
- ClinicalTrials.gov ID
- NCT03581799
- Acronym / sponsor ID
- 2017-01367
- Conditions
- Healthy
- Keywords
- Child
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 29 Jan 2018 (actual)
- Primary completion
- 12 Mar 2018 (actual)
- Study completion
- 12 Mar 2018 (actual)
- First posted
- 10 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a cross-sectional study investigating the palatability of an oral dispersible tablet with no pharmacologically active agent (carrier tablet) in children without underlying acute or chronic disease aged 2 to 10 years of age.
Detailed description
Oral dispersible tablets (ODTs) are a monolithic solid formulation potentially appropriate for a wide range of paediatric age groups. They also have a number of advantages over more frequently used formulation types, such as suspensions. Currently few Commercial products are available as ODTs for administration to children. Investigators aimed to investigate the palatability of an oral dispersible tablet with no pharmacologically active agent (carrier tablet) by assessing overall parent-reported, observer-reported and, where appropriate, child-reported acceptance of the formulation. In addition, investigators assessed the in situ disintegration behaviour of the carrier tablet.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oral dispersible tablet | Other | Other: Oral dispersible tablet5 mm calcium carbonate based ODT will be administered by placing it in the buccal pouch (children aged 2-5 years) or on the tongue (children aged 6-10 years). |
Who may qualify
- Ages
- 2 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Age between 2 and 10 years
- Attending study site as an outpatient during the study period.
- Informed consent form for study participation signed by legal guardian
- Verbal assent to participation from child
Key exclusion criteria (12 listed)
- Wearing dental braces
- Injuries or inflammatory disease affecting the oral cavity or throat
- Dysphagia
- Olfactory impairment
- Known renal impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral dispersible tabletAlso: Oral dispersible tablet (carrier tablet - no active pharmacological ingredient)Administration of a 5 mm calcium carbonate based ODT placed in the buccal pouch (children aged 2-5 years) or on the tongue (children aged 6-10 years). | Other | Oral dispersible tablet |
Primary outcome
Parent-reported palatability assessed by interview
Time frame: Day 1
5-point Likert scale, 1 "completely acceptable" to 5 "completely unacceptable"
Child-reported palatability (children aged 6-10 years only) assessed by interview
Time frame: Day 1
6-point Facial Hedonic Scale (0 "no discomfort on taking tablet" to 10 "maximum discomfort on taking tablet"
2 secondary outcomes
Observer-reported palatability assessed by questionnaire
Time frame: Day 1
In-situ disintegration behaviour of carrier tablet
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julia Bielicki, MD principal investigator
University of Basel Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral dispersible tablet in people with Healthy, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parent-reported palatability assessed by interview (time frame: Day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2018.