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The primary purpose of this protocol is to evaluate the lowest plasma concentration (ie before the daily taking dose of duloxetine) in patients relieved of at least 30% of their neuropathic pain with duloxetine treatment.
The secondary purpose of this protocol is to determine plasmatic concentration peak (ie 6 hours after taking duloxetine) in patients relieved of at least 30% of their neuropathic pain with duloxetine treatment.
Others secondary purposes are to evaluate the intensity of neuropathic pain, to assess the degree of pain relief and to evaluate the sensation of the global improvement experienced by the patient.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| patient treated by duloxetine | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| duloxetine | Drug | The concentration of duloxetine is measured by liquid chromatography coupled to tandem mass spectrometry on blood sample |
|
| Measure | Description | Time Frame |
|---|---|---|
| Measurement of the lowest plasma concentration of duloxetine in pmol/mL. | The concentration of duloxetine is measured by liquid chromatography coupled to tandem mass spectrometry on blood sample taken at the inclusion visit (V0), before the daily morning dose of duloxetine. |
| Measure | Description | Time Frame |
|---|---|---|
| Measurement of the plasma concentration peak of duloxetine in pmol/mL. | The concentration of duloxetine is measured by liquid chromatography coupled to tandem mass spectrometry on blood sample taken during the V1 visit (28 days after V0, 6 hours after the daily morning dose of duloxetine). |
| Measure | Description | Time Frame |
|---|---|---|
| Intensity of his pain assessed by Numeric Rating Scale (NRS) in 11 points. | The patient will daily report the intensity of his pain on a Numeric Rating Scale (NRS) in 11 points. The mean intensity of pain is measured at V0 and V1 visits. | at inclusion visit V0 and at V1 visit (28 days after the inclusion visit V0). |
Inclusion criteria:
Exclusion criteria:
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| Sensation of improvement |
The sensation of improvement experienced by the patient is assessed at V0 visit on a patient's global impression of change (PGIC) in 7 points scale. |
| at inclusion (V0 visit) |
| ID | Term |
|---|---|
| D009437 | Neuralgia |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000068736 | Duloxetine Hydrochloride |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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