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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-005911-94 | EudraCT Number |
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The purpose of this study is to evaluate the safety profile of a repeated application of a new transdermal patch compared to a reference product during 3 weeks, in a large population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| V0116 | Experimental | One patch per day (during 24 hours) for 21 days |
|
| Reference | Active Comparator | One patch per day (during 24 hours) for 21 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| V0116 transdermal patch | Drug | One patch per day (during 24 hours) for 21 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Safety | Evaluation of local safety (number of subjects with skin irritation / number of subjects by score of adhesiveness) and general safety (number of subjects with emergent adverse events or changes from baseline to end of study in vital signs, electrocardiogram and clinical laboratory parameters). | up to Day 22 |
| Measure | Description | Time Frame |
|---|---|---|
| Sensory profile | Visual Analogic Scales (sensations linked to patch application and removal) | Day 22 |
| Global assessment by the patient | Visual Analog Scale Scale and questionnaires |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gières | France | |||||
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| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| D014029 | Tobacco Use Disorder |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
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| ID | Term |
|---|---|
| D061485 | Tobacco Use Cessation Devices |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| Nicotine transdermal patch |
| Drug |
One patch per day (during 24 hours) for 21 days |
|
| Day 22 |
| Subject behaviours | nicotine consumption | up to Day 22 |
| Pierre-Bénite |
| France |
| Rennes | France |
| Rueil-Malmaison | France |
| D001523 |
| Mental Disorders |