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

NCT02846701 | Completed Phase 4

• 1 other identifier: 6314
• Study Type: interventional
• Target: 8
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Neuropathic Pain

Keywords

Neuropathic pain; Antidepressant; Duloxetine; Liquid Chromatography; Mass Spectrometry

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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 Outcomes (2)

• 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).

• Sensation of improvement

  at inclusion (V0 visit)

Study Arms (1)

patient treated by duloxetine

OTHER

Drug: duloxetine

Interventions

duloxetine DRUG

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

patient treated by duloxetine

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• concomitant treatment with enoxacin, fluvoxamine, flecainide, propafenone, metoprolol, risperidone, verapamil, omeprazole, modafinil, mequitazine, propafenone, tamoxifen, Monoamine Oxidase Inhibitors.

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

MeSH Terms

Conditions

Neuralgia

Interventions

Duloxetine Hydrochloride

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2016
• First Posted: July 27, 2016
• Study Start: November 17, 2016
• Primary Completion: June 20, 2017
• Study Completion: June 16, 2019
• Last Updated: July 15, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share