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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 : Unknown
Verified July 2016 by University Hospital, Strasbourg, France.
Recruitment status was:  Not yet recruiting
First Posted : July 27, 2016
Last Update Posted : July 27, 2016
Sponsor:
Information provided by (Responsible Party):
University Hospital, Strasbourg, France

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.


Condition or disease Intervention/treatment Phase
Neuropathic Pain Drug: duloxetine Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 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
Study Start Date : August 2016
Estimated Primary Completion Date : August 2017
Estimated Study Completion Date : August 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
patient treated by duloxetine Drug: duloxetine
The concentration of duloxetine is measured by liquid chromatography coupled to tandem mass spectrometry on blood sample




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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.



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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02846701


Contacts
Contact: Eric SALVAT, MD 3.88.12.76.13 ext 0033 eric.salvat@chru-strasbourg.fr

Sponsors and Collaborators
University Hospital, Strasbourg, France

Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT02846701     History of Changes
Other Study ID Numbers: 6314
First Posted: July 27, 2016    Key Record Dates
Last Update Posted: July 27, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by University Hospital, Strasbourg, France:
Neuropathic pain
Antidepressant
Duloxetine
Liquid Chromatography
Mass Spectrometry

Additional relevant MeSH terms:
Duloxetine Hydrochloride
Neuralgia
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Analgesics
Antidepressive Agents
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin and Noradrenaline Reuptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Dopamine Agents