Determination of the Antidepressant Duloxetine in Plasma to Improve the Knowledge of the Analgesic Action of Antidepressants on Chronic Neuropathic Pain

Neuropathic Pain Clinical Trial

— DULOPLASM  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02846701
• Other study ID #: 6314
• Status: Completed
• Phase: Phase 4
• Start date: November 17, 2016
• Est. completion date: June 16, 2019

Study information

• Verified date: July 2019
• Source: University Hospital, Strasbourg, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: June 16, 2019
• Est. primary completion date: June 20, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Neuralgia
• Neuropathic Pain

Intervention

Drug:
• duloxetine
The concentration of duloxetine is measured by liquid chromatography coupled to tandem mass spectrometry on blood sample

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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).
Other	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)
Primary	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	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).