Neuropathic Pain
Conditions
Keywords
Neuropathic pain, Antidepressant, Duloxetine, Liquid Chromatography, Mass Spectrometry
Brief summary
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.
Interventions
DRUGduloxetine
The concentration of duloxetine is measured by liquid chromatography coupled to tandem mass spectrometry on blood sample
Sponsors
University Hospital, Strasbourg, France
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* aged 40 to 75 years old * relieved of their neuropathic pain by 60 mg of duloxetine treatment (with a differential of\> 30% in the intensity of neuropathic pain with NRS, before and after treatment initiation)
Exclusion criteria
* concomitant treatment with enoxacin, fluvoxamine, flecainide, propafenone, metoprolol, risperidone, verapamil, omeprazole, modafinil, mequitazine, propafenone, tamoxifen, Monoamine Oxidase Inhibitors.
Design outcomes
Primary
| Measure | 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. |
Secondary
| Measure | 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). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Intensity of his pain assessed by Numeric Rating Scale (NRS) in 11 points. | at inclusion visit V0 and at V1 visit (28 days after the inclusion visit V0). | 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. |
| Sensation of improvement | at inclusion (V0 visit) | 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. |
Outcome results
None listed