Determination of the Antidepressant Duloxetine in Plasma to Improve the Knowledge of the Analgesic Action of Antidepressants on Chronic Neuropathic Pain (DULOPLASM)
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|ClinicalTrials.gov Identifier: NCT02846701|
Recruitment Status : Completed
First Posted : July 27, 2016
Last Update Posted : July 15, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Neuropathic Pain||Drug: duloxetine||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||8 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||DULOPLASM Study: Pilot Study on Mechanisms of Analgesic Action of Duloxetine: Effective Dosage of Duloxetine at the Peak and at the Lowest Plasma Concentrations|
|Actual Study Start Date :||November 17, 2016|
|Actual Primary Completion Date :||June 20, 2017|
|Actual Study Completion Date :||June 16, 2019|
|patient treated by duloxetine||
The concentration of duloxetine is measured by liquid chromatography coupled to tandem mass spectrometry on blood sample
- Measurement of the lowest plasma concentration of duloxetine in pmol/mL. [ Time Frame: 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. ]
- Measurement of the plasma concentration peak of duloxetine in pmol/mL. [ Time Frame: 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). ]
- Intensity of his pain assessed by Numeric Rating Scale (NRS) in 11 points. [ Time Frame: 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 [ Time Frame: 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.