MELA Study - Hedonic Study on the Taste of Drugs Crushed in Food: Observational Study Involving 16 Healthy Volunteers (MELA)
Study Overview
Status
Conditions
Intervention / Treatment
- Other: Jelly with:Paracetamol
- Other: Jelly with Furosemide
- Other: Jelly with Levothyroxine sodium salt
- Other: Jelly with Memantine
- Other: Jelly with Zopiclone
- Other: Jelly with Alprazolam
- Other: Jelly with Oxazepam
- Other: Jelly with Donepezil
- Other: Jelly with Clopidogrel
- Other: Jelly with Ramipril
- Other: Jelly with Paracetamol + Furosemide + Levothyroxine sodium salt + Memantine + Zopiclone + Alprazolam
- Other: Apple compote Paracetamol
- Other: Apple compote Furosemide
- Other: Apple compote Levothyroxine sodium salt
- Other: Apple compote Memantine
- Other: Apple compote Zopiclone
- Other: Apple compote Alprazolam
- Other: Apple compote Oxazepam
- Other: Apple compote Donepezil
- Other: Apple compote Clopidogrel
- Other: Apple compote Ramipril
- Other: Apple compote + Paracetamol + Furosemide + Levothyroxine sodium salt + Memantine + Zopiclone + Alprazolam
- Other: Plain apple compote control
- Other: Plain jelly control
Detailed Description
Background. Elderly people often suffer from chronic pathologies and they are given polypharmacy. In nursing homes, the residents take an average number of 6 to 8 active principles / day (Reference Geriatrics ward, Nice University Hospital, France), the equivalent of 10 to 20 medicines / day. But 40 % of the residents have swallowing disorders or cognitive impairment: the nursing staff is obliged to crush tablets and capsules and to give them mixed in a compote, a dairy or a jelly, for instance. Some experts groups (OMEDIT) have published a list of drugs authorized to be crushed, because this practice can modify the pharmacokinetics of certain active principles, and render them inactive or even toxic. However, the gustative aspect of crushed drugs has never been investigated.
Main objective. To identify from the advice of healthy volunteers, on the gustative aspect, which medicine it is acceptable or not recommended to add once crushed or opened in food.
Secondary objective. To search for alternative solutions. Type of study. Phase I study on healthy volunteers. It is a cohort study, with a hedonic, descriptive test in a single group and a single one session, to test the taste of 10 drugs crushed in some jelly and apple compote.
Volunteers participating in the study will be 16 healthy volunteers: 8 professionals of the restaurant, the catering, the food aromas, the nutrition and the dietetics, and 8 doctors, pharmacists, dental surgeons, nurses and/or nurse's aides.
Inclusion criteria: healthy volunteers over 18 years, without allergy known about 10 drugs to be tested. Pregnant women will not be included.
Criteria of evaluation:
- Quantitative: mark from 0 (bad taste) to 10 (no taste or no unpleasant taste) for the jelly and compote specimens mixed with crushed drugs.
- Qualitative: description of the perceived aroma (acid, bitter, sweet, salty, astringent, pricking, aromatic).
Brief description of the methodology:
The investigator shall test 10 drugs the most prescribed in the Korian group nursing homes, identified as being able to be crushed or opened. The assay will take place during a single one-morning session in a room specifically dedicated to clinical assays and with the help of a nursing staff trained for clinical assays (Nice University Hospital). Medicine will be crushed in parallel in some jelly and apple compote: 10 single drugs, 1 mixture of 6 drugs and 1 comparator (unmodified plain jelly and compote). Every volunteer will make these 24 tests blind and will fill a scoring sheet. He or she will spit out and have an oral rinse with some water between two tests; the dose susceptible to be ingested will be about 1/500th of a unit dosage. Excepted a risk of allergy, the medical risk is thus unimportant for the tasters. Unblinding will take place immediately after the end of the test. Every volunteer will propose alternative solutions.
Individual duration of the study. One morning. Total duration of the study. One year and half, for the organization of the test and the publication of the results.
Expected fallout
- The fight against senile anorexia and malnutrition, in elderly people who are given polypharmacy, by improving care protocols.
- Proposal of alternative solutions such as pediatric or galenic forms if they exist, other food substrates or new additives which would allow to mask the taste of certain drugs crushed in food.
- Incitement in a policy of reduction of drugs for the elderly.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
-
Nice, France, 06200
- Center for Clinical Research - Archet 1 Hospital Nice Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- healthy volunteers over 18 years.
Exclusion Criteria:
- pregnant women. Women in age to borne children will perform a urinary test will just before the assay, under the supervision of the Clinical Research Center nurse.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: Plain jelly control
|
A single dose of each drug will be opened (Paracetamol capsule) or crushed (tablets) in 100 ml of jelly (intervention 1-10) and in 100 ml of apple compote A mix of 6 drugs will be added to 100 ml of jelly (intervention 11) and in 100 ml of apple compote A negative control will consists in 100 ml of plain jelly or apple compote Each participant will receive 24 small transparent plastic glasses ("verrines") randomly allocated from number 1 to number 24, each verrine containing 5 ml of the initial 100 ml drug preparation. The participant will be blind to the verrine content. The participant will taste the verrine content with a 1 ml spoon and spit out each spoonful et rinse his or her mouth with plain water (Evian) between two tests. The participant will score each verrine numbered 1-24 with a mark ranging from 0 to 10 on the results scoring sheet. Unblinding will take place immediately after the end of the test. Every volunteer will propose alternative solutions. |
|
Active Comparator: Jelly with: Paracetamol
Jelly with: Paracetamol |
|
|
Active Comparator: Jelly with Furosemide
|
A single dose of each drug will be opened (Paracetamol capsule) or crushed (tablets) in 100 ml of jelly (intervention 1-10) and in 100 ml of apple compote A mix of 6 drugs will be added to 100 ml of jelly (intervention 11) and in 100 ml of apple compote A negative control will consists in 100 ml of plain jelly or apple compote Each participant will receive 24 small transparent plastic glasses ("verrines") randomly allocated from number 1 to number 24, each verrine containing 5 ml of the initial 100 ml drug preparation. The participant will be blind to the verrine content. The participant will taste the verrine content with a 1 ml spoon and spit out each spoonful et rinse his or her mouth with plain water (Evian) between two tests. The participant will score each verrine numbered 1-24 with a mark ranging from 0 to 10 on the results scoring sheet. Unblinding will take place immediately after the end of the test. Every volunteer will propose alternative solutions. |
|
Active Comparator: Jelly with Levothyroxine sodium salt
|
A single dose of each drug will be opened (Paracetamol capsule) or crushed (tablets) in 100 ml of jelly (intervention 1-10) and in 100 ml of apple compote A mix of 6 drugs will be added to 100 ml of jelly (intervention 11) and in 100 ml of apple compote A negative control will consists in 100 ml of plain jelly or apple compote Each participant will receive 24 small transparent plastic glasses ("verrines") randomly allocated from number 1 to number 24, each verrine containing 5 ml of the initial 100 ml drug preparation. The participant will be blind to the verrine content. The participant will taste the verrine content with a 1 ml spoon and spit out each spoonful et rinse his or her mouth with plain water (Evian) between two tests. The participant will score each verrine numbered 1-24 with a mark ranging from 0 to 10 on the results scoring sheet. Unblinding will take place immediately after the end of the test. Every volunteer will propose alternative solutions. |
|
Active Comparator: Jelly with memantine
|
A single dose of each drug will be opened (Paracetamol capsule) or crushed (tablets) in 100 ml of jelly (intervention 1-10) and in 100 ml of apple compote A mix of 6 drugs will be added to 100 ml of jelly (intervention 11) and in 100 ml of apple compote A negative control will consists in 100 ml of plain jelly or apple compote Each participant will receive 24 small transparent plastic glasses ("verrines") randomly allocated from number 1 to number 24, each verrine containing 5 ml of the initial 100 ml drug preparation. The participant will be blind to the verrine content. The participant will taste the verrine content with a 1 ml spoon and spit out each spoonful et rinse his or her mouth with plain water (Evian) between two tests. The participant will score each verrine numbered 1-24 with a mark ranging from 0 to 10 on the results scoring sheet. Unblinding will take place immediately after the end of the test. Every volunteer will propose alternative solutions. |
|
Active Comparator: jelly with zopiclone
Jelly with zopiclone
|
A single dose of each drug will be opened (Paracetamol capsule) or crushed (tablets) in 100 ml of jelly (intervention 1-10) and in 100 ml of apple compote A mix of 6 drugs will be added to 100 ml of jelly (intervention 11) and in 100 ml of apple compote A negative control will consists in 100 ml of plain jelly or apple compote Each participant will receive 24 small transparent plastic glasses ("verrines") randomly allocated from number 1 to number 24, each verrine containing 5 ml of the initial 100 ml drug preparation. The participant will be blind to the verrine content. The participant will taste the verrine content with a 1 ml spoon and spit out each spoonful et rinse his or her mouth with plain water (Evian) between two tests. The participant will score each verrine numbered 1-24 with a mark ranging from 0 to 10 on the results scoring sheet. Unblinding will take place immediately after the end of the test. Every volunteer will propose alternative solutions. |
|
Active Comparator: jelly with alprazolam
elly with alprazolam
|
A single dose of each drug will be opened (Paracetamol capsule) or crushed (tablets) in 100 ml of jelly (intervention 1-10) and in 100 ml of apple compote A mix of 6 drugs will be added to 100 ml of jelly (intervention 11) and in 100 ml of apple compote A negative control will consists in 100 ml of plain jelly or apple compote Each participant will receive 24 small transparent plastic glasses ("verrines") randomly allocated from number 1 to number 24, each verrine containing 5 ml of the initial 100 ml drug preparation. The participant will be blind to the verrine content. The participant will taste the verrine content with a 1 ml spoon and spit out each spoonful et rinse his or her mouth with plain water (Evian) between two tests. The participant will score each verrine numbered 1-24 with a mark ranging from 0 to 10 on the results scoring sheet. Unblinding will take place immediately after the end of the test. Every volunteer will propose alternative solutions. |
|
Active Comparator: jelly with Oxazepam
Jelly with Oxazepam
|
A single dose of each drug will be opened (Paracetamol capsule) or crushed (tablets) in 100 ml of jelly (intervention 1-10) and in 100 ml of apple compote A mix of 6 drugs will be added to 100 ml of jelly (intervention 11) and in 100 ml of apple compote A negative control will consists in 100 ml of plain jelly or apple compote Each participant will receive 24 small transparent plastic glasses ("verrines") randomly allocated from number 1 to number 24, each verrine containing 5 ml of the initial 100 ml drug preparation. The participant will be blind to the verrine content. The participant will taste the verrine content with a 1 ml spoon and spit out each spoonful et rinse his or her mouth with plain water (Evian) between two tests. The participant will score each verrine numbered 1-24 with a mark ranging from 0 to 10 on the results scoring sheet. Unblinding will take place immediately after the end of the test. Every volunteer will propose alternative solutions. |
|
Active Comparator: jelly with donepezil
|
A single dose of each drug will be opened (Paracetamol capsule) or crushed (tablets) in 100 ml of jelly (intervention 1-10) and in 100 ml of apple compote A mix of 6 drugs will be added to 100 ml of jelly (intervention 11) and in 100 ml of apple compote A negative control will consists in 100 ml of plain jelly or apple compote Each participant will receive 24 small transparent plastic glasses ("verrines") randomly allocated from number 1 to number 24, each verrine containing 5 ml of the initial 100 ml drug preparation. The participant will be blind to the verrine content. The participant will taste the verrine content with a 1 ml spoon and spit out each spoonful et rinse his or her mouth with plain water (Evian) between two tests. The participant will score each verrine numbered 1-24 with a mark ranging from 0 to 10 on the results scoring sheet. Unblinding will take place immediately after the end of the test. Every volunteer will propose alternative solutions. |
|
Active Comparator: Jelly with clopidogrel
jelly with clopidogrel
|
A single dose of each drug will be opened (Paracetamol capsule) or crushed (tablets) in 100 ml of jelly (intervention 1-10) and in 100 ml of apple compote A mix of 6 drugs will be added to 100 ml of jelly (intervention 11) and in 100 ml of apple compote A negative control will consists in 100 ml of plain jelly or apple compote Each participant will receive 24 small transparent plastic glasses ("verrines") randomly allocated from number 1 to number 24, each verrine containing 5 ml of the initial 100 ml drug preparation. The participant will be blind to the verrine content. The participant will taste the verrine content with a 1 ml spoon and spit out each spoonful et rinse his or her mouth with plain water (Evian) between two tests. The participant will score each verrine numbered 1-24 with a mark ranging from 0 to 10 on the results scoring sheet. Unblinding will take place immediately after the end of the test. Every volunteer will propose alternative solutions. |
|
Active Comparator: jelly with ramipril
|
A single dose of each drug will be opened (Paracetamol capsule) or crushed (tablets) in 100 ml of jelly (intervention 1-10) and in 100 ml of apple compote A mix of 6 drugs will be added to 100 ml of jelly (intervention 11) and in 100 ml of apple compote A negative control will consists in 100 ml of plain jelly or apple compote Each participant will receive 24 small transparent plastic glasses ("verrines") randomly allocated from number 1 to number 24, each verrine containing 5 ml of the initial 100 ml drug preparation. The participant will be blind to the verrine content. The participant will taste the verrine content with a 1 ml spoon and spit out each spoonful et rinse his or her mouth with plain water (Evian) between two tests. The participant will score each verrine numbered 1-24 with a mark ranging from 0 to 10 on the results scoring sheet. Unblinding will take place immediately after the end of the test. Every volunteer will propose alternative solutions. |
|
Active Comparator: jelly with Paracetamol + Furosemide + Levothyroxine sodium sa
Jelly with Paracetamol + Furosemide + Levothyroxine sodium salt + Memantine + Zopiclone + Alprazolam
|
A single dose of each drug will be opened (Paracetamol capsule) or crushed (tablets) in 100 ml of jelly (intervention 1-10) and in 100 ml of apple compote A mix of 6 drugs will be added to 100 ml of jelly (intervention 11) and in 100 ml of apple compote A negative control will consists in 100 ml of plain jelly or apple compote Each participant will receive 24 small transparent plastic glasses ("verrines") randomly allocated from number 1 to number 24, each verrine containing 5 ml of the initial 100 ml drug preparation. The participant will be blind to the verrine content. The participant will taste the verrine content with a 1 ml spoon and spit out each spoonful et rinse his or her mouth with plain water (Evian) between two tests. The participant will score each verrine numbered 1-24 with a mark ranging from 0 to 10 on the results scoring sheet. Unblinding will take place immediately after the end of the test. Every volunteer will propose alternative solutions. |
|
Placebo Comparator: Plain apple compote control
|
A single dose of each drug will be opened (Paracetamol capsule) or crushed (tablets) in 100 ml of jelly (intervention 1-10) and in 100 ml of apple compote A mix of 6 drugs will be added to 100 ml of jelly (intervention 11) and in 100 ml of apple compote A negative control will consists in 100 ml of plain jelly or apple compote Each participant will receive 24 small transparent plastic glasses ("verrines") randomly allocated from number 1 to number 24, each verrine containing 5 ml of the initial 100 ml drug preparation. The participant will be blind to the verrine content. The participant will taste the verrine content with a 1 ml spoon and spit out each spoonful et rinse his or her mouth with plain water (Evian) between two tests. The participant will score each verrine numbered 1-24 with a mark ranging from 0 to 10 on the results scoring sheet. Unblinding will take place immediately after the end of the test. Every volunteer will propose alternative solutions. |
|
Active Comparator: Apple compote Paracetamol
|
A single dose of each drug will be opened (Paracetamol capsule) or crushed (tablets) in 100 ml of jelly (intervention 1-10) and in 100 ml of apple compote A mix of 6 drugs will be added to 100 ml of jelly (intervention 11) and in 100 ml of apple compote A negative control will consists in 100 ml of plain jelly or apple compote Each participant will receive 24 small transparent plastic glasses ("verrines") randomly allocated from number 1 to number 24, each verrine containing 5 ml of the initial 100 ml drug preparation. The participant will be blind to the verrine content. The participant will taste the verrine content with a 1 ml spoon and spit out each spoonful et rinse his or her mouth with plain water (Evian) between two tests. The participant will score each verrine numbered 1-24 with a mark ranging from 0 to 10 on the results scoring sheet. Unblinding will take place immediately after the end of the test. Every volunteer will propose alternative solutions. |
|
Active Comparator: Apple compote Furosemide
|
A single dose of each drug will be opened (Paracetamol capsule) or crushed (tablets) in 100 ml of jelly (intervention 1-10) and in 100 ml of apple compote A mix of 6 drugs will be added to 100 ml of jelly (intervention 11) and in 100 ml of apple compote A negative control will consists in 100 ml of plain jelly or apple compote Each participant will receive 24 small transparent plastic glasses ("verrines") randomly allocated from number 1 to number 24, each verrine containing 5 ml of the initial 100 ml drug preparation. The participant will be blind to the verrine content. The participant will taste the verrine content with a 1 ml spoon and spit out each spoonful et rinse his or her mouth with plain water (Evian) between two tests. The participant will score each verrine numbered 1-24 with a mark ranging from 0 to 10 on the results scoring sheet. Unblinding will take place immediately after the end of the test. Every volunteer will propose alternative solutions. |
|
Active Comparator: Apple compote Levothyroxine sodium salt
|
A single dose of each drug will be opened (Paracetamol capsule) or crushed (tablets) in 100 ml of jelly (intervention 1-10) and in 100 ml of apple compote A mix of 6 drugs will be added to 100 ml of jelly (intervention 11) and in 100 ml of apple compote A negative control will consists in 100 ml of plain jelly or apple compote Each participant will receive 24 small transparent plastic glasses ("verrines") randomly allocated from number 1 to number 24, each verrine containing 5 ml of the initial 100 ml drug preparation. The participant will be blind to the verrine content. The participant will taste the verrine content with a 1 ml spoon and spit out each spoonful et rinse his or her mouth with plain water (Evian) between two tests. The participant will score each verrine numbered 1-24 with a mark ranging from 0 to 10 on the results scoring sheet. Unblinding will take place immediately after the end of the test. Every volunteer will propose alternative solutions. |
|
Active Comparator: Apple compote Memantine
|
A single dose of each drug will be opened (Paracetamol capsule) or crushed (tablets) in 100 ml of jelly (intervention 1-10) and in 100 ml of apple compote A mix of 6 drugs will be added to 100 ml of jelly (intervention 11) and in 100 ml of apple compote A negative control will consists in 100 ml of plain jelly or apple compote Each participant will receive 24 small transparent plastic glasses ("verrines") randomly allocated from number 1 to number 24, each verrine containing 5 ml of the initial 100 ml drug preparation. The participant will be blind to the verrine content. The participant will taste the verrine content with a 1 ml spoon and spit out each spoonful et rinse his or her mouth with plain water (Evian) between two tests. The participant will score each verrine numbered 1-24 with a mark ranging from 0 to 10 on the results scoring sheet. Unblinding will take place immediately after the end of the test. Every volunteer will propose alternative solutions. |
|
Active Comparator: Apple compote Zopiclone
|
A single dose of each drug will be opened (Paracetamol capsule) or crushed (tablets) in 100 ml of jelly (intervention 1-10) and in 100 ml of apple compote A mix of 6 drugs will be added to 100 ml of jelly (intervention 11) and in 100 ml of apple compote A negative control will consists in 100 ml of plain jelly or apple compote Each participant will receive 24 small transparent plastic glasses ("verrines") randomly allocated from number 1 to number 24, each verrine containing 5 ml of the initial 100 ml drug preparation. The participant will be blind to the verrine content. The participant will taste the verrine content with a 1 ml spoon and spit out each spoonful et rinse his or her mouth with plain water (Evian) between two tests. The participant will score each verrine numbered 1-24 with a mark ranging from 0 to 10 on the results scoring sheet. Unblinding will take place immediately after the end of the test. Every volunteer will propose alternative solutions. |
|
Active Comparator: Apple compote Alprazolam
|
A single dose of each drug will be opened (Paracetamol capsule) or crushed (tablets) in 100 ml of jelly (intervention 1-10) and in 100 ml of apple compote A mix of 6 drugs will be added to 100 ml of jelly (intervention 11) and in 100 ml of apple compote A negative control will consists in 100 ml of plain jelly or apple compote Each participant will receive 24 small transparent plastic glasses ("verrines") randomly allocated from number 1 to number 24, each verrine containing 5 ml of the initial 100 ml drug preparation. The participant will be blind to the verrine content. The participant will taste the verrine content with a 1 ml spoon and spit out each spoonful et rinse his or her mouth with plain water (Evian) between two tests. The participant will score each verrine numbered 1-24 with a mark ranging from 0 to 10 on the results scoring sheet. Unblinding will take place immediately after the end of the test. Every volunteer will propose alternative solutions. |
|
Active Comparator: Apple compote Oxazepam
|
A single dose of each drug will be opened (Paracetamol capsule) or crushed (tablets) in 100 ml of jelly (intervention 1-10) and in 100 ml of apple compote A mix of 6 drugs will be added to 100 ml of jelly (intervention 11) and in 100 ml of apple compote A negative control will consists in 100 ml of plain jelly or apple compote Each participant will receive 24 small transparent plastic glasses ("verrines") randomly allocated from number 1 to number 24, each verrine containing 5 ml of the initial 100 ml drug preparation. The participant will be blind to the verrine content. The participant will taste the verrine content with a 1 ml spoon and spit out each spoonful et rinse his or her mouth with plain water (Evian) between two tests. The participant will score each verrine numbered 1-24 with a mark ranging from 0 to 10 on the results scoring sheet. Unblinding will take place immediately after the end of the test. Every volunteer will propose alternative solutions. |
|
Active Comparator: Apple compote Donepezil
|
A single dose of each drug will be opened (Paracetamol capsule) or crushed (tablets) in 100 ml of jelly (intervention 1-10) and in 100 ml of apple compote A mix of 6 drugs will be added to 100 ml of jelly (intervention 11) and in 100 ml of apple compote A negative control will consists in 100 ml of plain jelly or apple compote Each participant will receive 24 small transparent plastic glasses ("verrines") randomly allocated from number 1 to number 24, each verrine containing 5 ml of the initial 100 ml drug preparation. The participant will be blind to the verrine content. The participant will taste the verrine content with a 1 ml spoon and spit out each spoonful et rinse his or her mouth with plain water (Evian) between two tests. The participant will score each verrine numbered 1-24 with a mark ranging from 0 to 10 on the results scoring sheet. Unblinding will take place immediately after the end of the test. Every volunteer will propose alternative solutions. |
|
Active Comparator: Apple compote Clopidogrel
|
A single dose of each drug will be opened (Paracetamol capsule) or crushed (tablets) in 100 ml of jelly (intervention 1-10) and in 100 ml of apple compote A mix of 6 drugs will be added to 100 ml of jelly (intervention 11) and in 100 ml of apple compote A negative control will consists in 100 ml of plain jelly or apple compote Each participant will receive 24 small transparent plastic glasses ("verrines") randomly allocated from number 1 to number 24, each verrine containing 5 ml of the initial 100 ml drug preparation. The participant will be blind to the verrine content. The participant will taste the verrine content with a 1 ml spoon and spit out each spoonful et rinse his or her mouth with plain water (Evian) between two tests. The participant will score each verrine numbered 1-24 with a mark ranging from 0 to 10 on the results scoring sheet. Unblinding will take place immediately after the end of the test. Every volunteer will propose alternative solutions. |
|
Active Comparator: Apple compote Ramipril
|
A single dose of each drug will be opened (Paracetamol capsule) or crushed (tablets) in 100 ml of jelly (intervention 1-10) and in 100 ml of apple compote A mix of 6 drugs will be added to 100 ml of jelly (intervention 11) and in 100 ml of apple compote A negative control will consists in 100 ml of plain jelly or apple compote Each participant will receive 24 small transparent plastic glasses ("verrines") randomly allocated from number 1 to number 24, each verrine containing 5 ml of the initial 100 ml drug preparation. The participant will be blind to the verrine content. The participant will taste the verrine content with a 1 ml spoon and spit out each spoonful et rinse his or her mouth with plain water (Evian) between two tests. The participant will score each verrine numbered 1-24 with a mark ranging from 0 to 10 on the results scoring sheet. Unblinding will take place immediately after the end of the test. Every volunteer will propose alternative solutions. |
|
Active Comparator: Apple Paracetamol Furosemide Levothyroxine NACL Memantine Zopi
Apple Paracetamol Furosemide Levothyroxine NACL Memantine Zopiclone Alprazolam
|
A single dose of each drug will be opened (Paracetamol capsule) or crushed (tablets) in 100 ml of jelly (intervention 1-10) and in 100 ml of apple compote A mix of 6 drugs will be added to 100 ml of jelly (intervention 11) and in 100 ml of apple compote A negative control will consists in 100 ml of plain jelly or apple compote Each participant will receive 24 small transparent plastic glasses ("verrines") randomly allocated from number 1 to number 24, each verrine containing 5 ml of the initial 100 ml drug preparation. The participant will be blind to the verrine content. The participant will taste the verrine content with a 1 ml spoon and spit out each spoonful et rinse his or her mouth with plain water (Evian) between two tests. The participant will score each verrine numbered 1-24 with a mark ranging from 0 to 10 on the results scoring sheet. Unblinding will take place immediately after the end of the test. Every volunteer will propose alternative solutions. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Quantitative- compare the taste between specimens
Time Frame: 1 week after the test
|
Quantitative: mark from 0 (bad taste) to 10 (no taste or no unpleasant taste) for the jelly and compote specimens added with crushed drugs.
|
1 week after the test
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
qualitative - description of the perceived aroma
Time Frame: 1 week after the test
|
Qualitative: description of the perceived aroma (acid, bitter, sweet, salty, astringent, pricking, aromatic).
|
1 week after the test
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Wounds and Injuries
- Crush Injuries
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Antihypertensive Agents
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Cholinergic Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Excitatory Amino Acid Antagonists
- Excitatory Amino Acid Agents
- Analgesics, Non-Narcotic
- Platelet Aggregation Inhibitors
- Antipyretics
- Purinergic P2Y Receptor Antagonists
- Purinergic P2 Receptor Antagonists
- Purinergic Antagonists
- Purinergic Agents
- Protease Inhibitors
- Natriuretic Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Membrane Transport Modulators
- Dopamine Agents
- Hypnotics and Sedatives
- Anti-Anxiety Agents
- GABA Modulators
- GABA Agents
- Diuretics
- Nootropic Agents
- Angiotensin-Converting Enzyme Inhibitors
- Antiparkinson Agents
- Anti-Dyskinesia Agents
- Cholinesterase Inhibitors
- Sodium Potassium Chloride Symporter Inhibitors
- Clopidogrel
- Acetaminophen
- Donepezil
- Furosemide
- Ramipril
- Memantine
- Alprazolam
- Zopiclone
- Oxazepam
Other Study ID Numbers
- 2013-003461-34
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Showa Inan General HospitalCompleted
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Kaohsiung Medical University Chung-Ho Memorial...RecruitingMuscle Weakness | Elderly | Nutrition, HealthyTaiwan
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Dental Innovation Foundation Under Royal PatronageMahidol University; Ministry of Health, Thailand; Thammasat University; Srinakharinwirot...CompletedHead and Neck Cancer | DysphagiaThailand
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Chang Gung Memorial HospitalRecruitingDry Eye Syndromes | Sjogren's SyndromeTaiwan
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Universidade Federal FluminenseCoordenação de Aperfeiçoamento de Pessoal de Nível Superior.; Conselho Nacional... and other collaboratorsRecruitingCardiovascular Diseases | Hypertension | Chronic Kidney DiseasesBrazil
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Prof. Thomas EngelhardtUnknownTonsillectomy | Adenoidectomy | POSTOP NAUSEA VOMITING
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Dental Innovation Foundation Under Royal PatronageMahidol University; Srinakharinwirot University; Maha Vajiralongkorn Thanyaburi...CompletedHead and Neck Cancer