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Completed

NCT Number: NCT02846701

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

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.

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Key information

Conditions

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

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Duloxetine

Drug

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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).

Other outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

University Hospital, Strasbourg, France

Other

Registry information

Official study 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

Acronym: DULOPLASM

Important dates

Study start
2016
Primary completion
2017
Study completion
2019
First posted
Jul 27, 2016
Registry last updated
Jul 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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