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

NCT ID: NCT02846701

Last Updated: 2019-07-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-17

Study Completion Date

2019-06-16

Brief Summary

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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.

Detailed Description

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Conditions

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Neuropathic Pain

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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patient treated by duloxetine

Group Type OTHER

duloxetine

Intervention Type DRUG

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

Interventions

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duloxetine

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Strasbourg, France

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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6314

Identifier Type: -

Identifier Source: org_study_id

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