HealthyNCT06358586
New Paediatric Formulation of Tachipirina®
A study testing Tachipirina® 120 mg/5 mL oral suspension, new flavour in people with Healthy, run by Aziende Chimiche Riunite Angelini Francesco S.p.A at 1 site in Switzerland.
Trial summary
This is a single centre, single dose, single-arm, open-label, palatability study. The aim of the present study is to investigate the palatability of the newly developed Tachipirina® 120 mg/5 mL oral suspension with strawberry flavour. Read more about this study
- Who is it for?
- Ages 6 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Tachipirina® 120 mg/5 mL oral suspension, new flavour
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSwitzerland
- Study dates
- 9 Apr 2022to 25 Apr 2022
- 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 6 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Sex and Age: males or females, 6-17 years old inclusive
- Body Mass Index: males/females not classified as overweight based on the applicable body mass index chart for sex and age
- Informed consent and assent: signed written informed consent by both parents/legal representatives unless only one has legal authority. Signed written informed assent for 14-17 years old inclusive adolescents or written informed assent for 11-13 years old inclusive children or oral informed assent for 6-10 years old inclusive children.
- Full comprehension: ability of the paediatric volunteer and parent(s)/legal representative(s) to comprehend the full nature and purpose of the study, including possible risks and side effects; ability of the paediatric volunteer and parent(s)/legal representative(s) to co-operate with the Investigator and to comply with the requirements of the entire study
- Ascertained tolerability to paracetamol: history of intake of Tachipirina® or its active ingredient, i.e., paracetamol, with no consequent adverse reaction
Who cannot join
- Physical findings: clinically significant abnormal physical findings which could interfere with the objectives of the study
- Allergy: ascertained or presumptive hypersensitivity to the active principle and/or formulations' ingredients; history of anaphylaxis to drugs or allergic reactions in general, which the Investigator considers may affect the outcome of the study
- Diseases: history of significant renal, hepatic, gastrointestinal, cardiovascular, respiratory, skin, haematological, endocrine or neurological diseases that may interfere with the aim of the study; mouth lesions or any other oral mucosa alteration that may interfere with the aim of the study according to the Investigator's opinion
- Medications: medications, including over the counter medications and herbal remedies for 2 weeks before the start of the study that may interfere with the aim of the study according to the Investigator's opinion. Hormonal contraceptives for child-bearing potential females (i.e., post-menarche) will be allowed
- Tobacco: smokers will not be admitted
- Investigative drug studies: participation in the evaluation of any investigational medicinal product for 3 months before this study. The 3-month interval will be calculated as the time between the first calendar day of the month that follows the last visit of the previous study and the first day of the present study
Show all 11Show fewer
- Diet: abnormal diets or substantial changes in eating habits in the 4 weeks before this study that may interfere with the aim of the study according to the Investigator's opinion
- SARS-CoV-2 test: positive Covid-19 Antigen Rapid Test at screening of paediatric volunteer or parent(s)/legal representative(s)
- Drug test: only for adolescents 12-17 years old inclusive, positive drug test at screening
- Alcohol breath test: only for adolescents 12-17 years old inclusive, positive alcohol breath test at screening
- Pregnancy: only for child-bearing potential females (i.e., post-menarche), positive or missing pregnancy test at screening
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Palatability Study of a Novel Paediatric Formulation of Tachipirina® With Strawberry Flavour
This is a single centre, single dose, single-arm, open-label, palatability study.
The aim of the present study is to investigate the palatability of the newly developed Tachipirina® 120 mg/5 mL oral suspension with strawberry flavour. The study will be conducted in paediatric volunteers that represent the target population for this product.
Read the detailed description
Twenty (20) healthy paediatric volunteers aged 6-17 years old inclusive will be enrolled in the study.
The primary end-point is to assess the palatability of the new strawberry flavour after single dose administration of the Investigation Medicine Product (IMP) through a questionnaire.
The secondary end-points is to monitor the safety and tolerability data after single dose administration of the Investigation Medicine Product (IMP).
- Conditions
- Healthy
- Being tested
- Tachipirina® 120 mg/5 mL oral suspension, new flavour
- Keywords
- palatability, strawberry flavour, Tachipirina, novel formulation, paediatric
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tachipirina® 120 mg/5 mL oral suspension, new flavourDrug
A single oral dose of the Tachipirina® 120 mg/5 mL oral suspension(10 mL) will be administered to healthy paediatric volunteers under fasting conditions for at least 1 h before IMP administration until completion of palatability assessment.
| Study group | Role | What they receive |
|---|---|---|
| Tachipirina® 120 mg/5 mL oral suspension, strawberry flavour | Experimental | All healthy paediatric volunteers administered with the mediation Receives: Drug: Tachipirina® 120 mg/5 mL oral suspension, new flavour |
What is being measured
The primary outcome is the main question the study is designed to answer.
Palatability of new flavour - Taste (1)
Subject are asked: How do you describe the taste of this medication? The corresponding answer are sweet, salty, sour, bitter.
Measured: 15 minutes after investigational medicinal product administration
Palatability of new flavour - Taste (2)
Subject are asked: How much do you like the taste of this medication? The corresponding answer are given using a hedonic facial scale i.e. the 7-points rating Chen scale in which descriptive replies are associated to images showing different facial expressions to allow the children to easily quantitate their sensory experiences. For the Chen scale, a numeric score will be assigned by the Investigator as follows:
- Very bad = 1
- Bad = 2
- Just a little bad = 3
- Not sure = 4
- Just a little good = 5
- Good = 6
- Very good = 7
Measured: 15 minutes after investigational medicinal product administration
Palatability of new flavour - Smell
Subject are asked: How much do you like the smell of this medication? The corresponding answer are given using a hedonic facial scale i.e. the 7-points rating Chen scale in which descriptive replies are associated to images showing different facial expressions to allow the children to easily quantitate their sensory experiences. For the Chen scale, a numeric score will be assigned by the Investigator as follows:
- Very bad = 1
- Bad = 2
- Just a little bad = 3
- Not sure = 4
- Just a little good = 5
- Good = 6
- Very good = 7
Measured: 15 minutes after investigational medicinal product administration
Palatability of new flavour - Aftertaste (1)
Subject are asked: Do you feel an aftertaste after the administration of this medication? The corresponding answer are Yes or No.
Measured: 15 minutes after investigational medicinal product administration
Palatability of new flavour - Aftertaste (2)
If Subjects reply Yes to the previous question they are asked: Do you describe the aftertaste of this medication? The corresponding answer are sweet, salty, sour, bitter.
Measured: 15 minutes after investigational medicinal product administration
Palatability of new flavour - Aftertaste (3)
If Subjects replies Yes to the previous question they are asked: How much do you like the aftertaste of this medication? The corresponding answer are given using a hedonic facial scale i.e. the 7-points rating Chen scale in which descriptive replies are associated to images showing different facial expressions to allow the children to easily quantitate their sensory experiences. For the Chen scale, a numeric score will be assigned by the Investigator as follows:
- Very bad = 1
- Bad = 2
- Just a little bad = 3
- Not sure = 4
- Just a little good = 5
- Good = 6
- Very good = 7
Measured: 15 minutes after investigational medicinal product administration
Palatability of new flavour - Texture (mouthfeel)
Subject are asked: How do you describe the texture of this medication in the mouth? The corresponding answer are Thin, thick, gritty.
Measured: 15 minutes after investigational medicinal product administration
Palatability of new flavour - Overall
Subject are asked: In general, how much do you like this medication?The corresponding answer are given using a hedonic facial scale i.e. the 7-points rating Chen scale in which descriptive replies are associated to images showing different facial expressions to allow the children to easily quantitate their sensory experiences. For the Chen scale, a numeric score will be assigned by the Investigator as follows:
- Very bad = 1
- Bad = 2
- Just a little bad = 3
- Not sure = 4
- Just a little good = 5
- Good = 6
- Very good = 7
Measured: 15 minutes after investigational medicinal product administration
Secondary outcomes (1)
Treatment emergent adverse events (TEAEs)
Number of TEAEs after single dose administration of the investigational medicinal product.
Measured: Through study completion, an average of 2 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2024
- Study start9 Apr 2022
- Primary completion25 Apr 2022
- Study completion25 Apr 2022
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.
- 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
- Model description
- Single centre, single dose, single-arm, open-label, palatability study
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aziende Chimiche Riunite Angelini Francesco S.p.A
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Cross S.A.
- Responsible party
- Sponsor
- Investigators
- Milko Radicioni, Principal investigator, CROSS Research S.A. - Phase I Unit,
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06358586
- Sponsor's protocol ID
- 044(H)MD21176
- Other IDs
- CRO-PK-21-356
- Status last verified
- Apr 2024
- First submitted
- 2 Apr 2024
- Last updated
- 10 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Palatability Study of a Novel Paediatric Formulation of Tachipirina® With Strawberry Flavour
- ClinicalTrials.gov ID
- NCT06358586
- Acronym / sponsor ID
- 044(H)MD21176
- Conditions
- Healthy
- Keywords
- palatability, strawberry flavour, Tachipirina, novel formulation, paediatric
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Aziende Chimiche Riunite Angelini Francesco S.p.AIndustry (pharma, biotech, devices)
- Collaborators
- Cross S.A.
- Study start
- 9 Apr 2022 (actual)
- Primary completion
- 25 Apr 2022 (actual)
- Study completion
- 25 Apr 2022 (actual)
- First posted
- 10 Apr 2024 (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 single centre, single dose, single-arm, open-label, palatability study.
The aim of the present study is to investigate the palatability of the newly developed Tachipirina® 120 mg/5 mL oral suspension with strawberry flavour. The study will be conducted in paediatric volunteers that represent the target population for this product.
Detailed description
Twenty (20) healthy paediatric volunteers aged 6-17 years old inclusive will be enrolled in the study.
The primary end-point is to assess the palatability of the new strawberry flavour after single dose administration of the Investigation Medicine Product (IMP) through a questionnaire.
The secondary end-points is to monitor the safety and tolerability data after single dose administration of the Investigation Medicine Product (IMP).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single centre, single dose, single-arm, open-label, palatability study
| Arm | Type | Receives |
|---|---|---|
| Tachipirina® 120 mg/5 mL oral suspension, strawberry flavour | Experimental | Drug: Tachipirina® 120 mg/5 mL oral suspension, new flavourAll healthy paediatric volunteers administered with the mediation |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Sex and Age: males or females, 6-17 years old inclusive
- Body Mass Index: males/females not classified as overweight based on the applicable body mass index chart for sex and age
- Informed consent and assent: signed written informed consent by both parents/legal representatives unless only one has legal authority. Signed written informed assent for 14-17 years old inclusive adolescents or written informed assent for 11-13 years old inclusive children or oral informed assent for 6-10 years old inclusive children.
- Full comprehension: ability of the paediatric volunteer and parent(s)/legal representative(s) to comprehend the full nature and purpose of the study, including possible risks and side effects; ability of the paediatric volunteer and parent(s)/legal representative(s) to co-operate with the Investigator and to comply with the requirements of the entire study
- Ascertained tolerability to paracetamol: history of intake of Tachipirina® or its active ingredient, i.e., paracetamol, with no consequent adverse reaction
Key exclusion criteria (11 listed)
- Physical findings: clinically significant abnormal physical findings which could interfere with the objectives of the study
- Allergy: ascertained or presumptive hypersensitivity to the active principle and/or formulations' ingredients; history of anaphylaxis to drugs or allergic reactions in general, which the Investigator considers may affect the outcome of the study
- Diseases: history of significant renal, hepatic, gastrointestinal, cardiovascular, respiratory, skin, haematological, endocrine or neurological diseases that may interfere with the aim of the study; mouth lesions or any other oral mucosa alteration that may interfere with the aim of the study according to the Investigator's opinion
- Medications: medications, including over the counter medications and herbal remedies for 2 weeks before the start of the study that may interfere with the aim of the study according to the Investigator's opinion. Hormonal contraceptives for child-bearing potential females (i.e., post-menarche) will be allowed
- Tobacco: smokers will not be admitted
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 |
|---|---|---|
| Tachipirina® 120 mg/5 mL oral suspension, new flavourA single oral dose of the Tachipirina® 120 mg/5 mL oral suspension(10 mL) will be administered to healthy paediatric volunteers under fasting conditions for at least 1 h before IMP administration until completion of palatability assessment. | Drug | Tachipirina® 120 mg/5 mL oral suspension, strawberry flavour |
Primary outcome
Palatability of new flavour - Taste (1)
Time frame: 15 minutes after investigational medicinal product administration
Subject are asked: How do you describe the taste of this medication? The corresponding answer are sweet, salty, sour, bitter.
Palatability of new flavour - Taste (2)
Time frame: 15 minutes after investigational medicinal product administration
Subject are asked: How much do you like the taste of this medication? The corresponding answer are given using a hedonic facial scale i.e. the 7-points rating Chen scale in which descriptive replies are associated to images showing different facial expressions to allow the children to easily quantitate their sensory experiences. For the Chen scale, a numeric score will be assigned by the Investigator as follows: * Very bad = 1 * Bad = 2 * Just a little bad = 3 * Not sure = 4 * Just a little good = 5 * Good = 6 * Very good = 7
Palatability of new flavour - Smell
Time frame: 15 minutes after investigational medicinal product administration
Subject are asked: How much do you like the smell of this medication? The corresponding answer are given using a hedonic facial scale i.e. the 7-points rating Chen scale in which descriptive replies are associated to images showing different facial expressions to allow the children to easily quantitate their sensory experiences. For the Chen scale, a numeric score will be assigned by the Investigator as follows: * Very bad = 1 * Bad = 2 * Just a little bad = 3 * Not sure = 4 * Just a little good = 5 * Good = 6 * Very good = 7
Palatability of new flavour - Aftertaste (1)
Time frame: 15 minutes after investigational medicinal product administration
Subject are asked: Do you feel an aftertaste after the administration of this medication? The corresponding answer are Yes or No.
Palatability of new flavour - Aftertaste (2)
Time frame: 15 minutes after investigational medicinal product administration
If Subjects reply Yes to the previous question they are asked: Do you describe the aftertaste of this medication? The corresponding answer are sweet, salty, sour, bitter.
Palatability of new flavour - Aftertaste (3)
Time frame: 15 minutes after investigational medicinal product administration
If Subjects replies Yes to the previous question they are asked: How much do you like the aftertaste of this medication? The corresponding answer are given using a hedonic facial scale i.e. the 7-points rating Chen scale in which descriptive replies are associated to images showing different facial expressions to allow the children to easily quantitate their sensory experiences. For the Chen scale, a numeric score will be assigned by the Investigator as follows: * Very bad = 1 * Bad = 2 * Just a little bad = 3 * Not sure = 4 * Just a little good = 5 * Good = 6 * Very good = 7
Palatability of new flavour - Texture (mouthfeel)
Time frame: 15 minutes after investigational medicinal product administration
Subject are asked: How do you describe the texture of this medication in the mouth? The corresponding answer are Thin, thick, gritty.
Palatability of new flavour - Overall
Time frame: 15 minutes after investigational medicinal product administration
Subject are asked: In general, how much do you like this medication?The corresponding answer are given using a hedonic facial scale i.e. the 7-points rating Chen scale in which descriptive replies are associated to images showing different facial expressions to allow the children to easily quantitate their sensory experiences. For the Chen scale, a numeric score will be assigned by the Investigator as follows: * Very bad = 1 * Bad = 2 * Just a little bad = 3 * Not sure = 4 * Just a little good = 5 * Good = 6 * Very good = 7
1 secondary outcome
Treatment emergent adverse events (TEAEs)
Time frame: Through study completion, an average of 2 weeks.
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 10 Apr 2024.
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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.
Milko Radicioni principal investigator
CROSS Research S.A. - Phase I Unit,
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tachipirina® 120 mg/5 mL oral suspension, new flavour in people with Healthy, run by Aziende Chimiche Riunite Angelini Francesco S.p.A 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 5 inclusion and 11 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 10 Apr 2024. 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?
Palatability of new flavour - Taste (1) (time frame: 15 minutes after investigational medicinal product administration). The study lists 8 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 10 Apr 2024; AzTrials last refreshed its copy on 6 Nov 2026.