Back to resultsDetermination of the Antidepressant Duloxetine in Plasma to Improve the Knowledge of the Analgesic Action of Antidepressants on Chronic Neuropathic Pain (DULOPLASM)
Primary Purpose
Neuropathic Pain
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
duloxetine
Sponsored by
About this trial
This is an interventional other trial for Neuropathic Pain focused on measuring Neuropathic pain, Antidepressant, Duloxetine, Liquid Chromatography, Mass Spectrometry
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
patient treated by duloxetine
Arm Description
Outcomes
Primary Outcome Measures
Measurement of the lowest plasma concentration of duloxetine in pmol/mL.
Secondary Outcome Measures
Measurement of the plasma concentration peak of duloxetine in pmol/mL.
Full Information
NCT ID
NCT02846701
First Posted
July 1, 2016
Last Updated
July 10, 2019
Sponsor
University Hospital, Strasbourg, France
1. Study Identification
Unique Protocol Identification Number
NCT02846701
Brief Title
Determination of the Antidepressant Duloxetine in Plasma to Improve the Knowledge of the Analgesic Action of Antidepressants on Chronic Neuropathic Pain
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
November 17, 2016 (Actual)
Primary Completion Date
June 20, 2017 (Actual)
Study Completion Date
June 16, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Strasbourg, France
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuropathic Pain
Keywords
Neuropathic pain, Antidepressant, Duloxetine, Liquid Chromatography, Mass Spectrometry
7. Study Design
Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
patient treated by duloxetine
Arm Type
Other
Intervention Type
Drug
Intervention Name(s)
duloxetine
Intervention Description
The concentration of duloxetine is measured by liquid chromatography coupled to tandem mass spectrometry on blood sample
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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 Pre-specified Outcome Measures:
Title
Intensity of his pain assessed by Numeric Rating Scale (NRS) in 11 points.
Description
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.
Time Frame
at inclusion visit V0 and at V1 visit (28 days after the inclusion visit V0).
Title
Sensation of improvement
Description
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.
Time Frame
at inclusion (V0 visit)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Determination of the Antidepressant Duloxetine in Plasma to Improve the Knowledge of the Analgesic Action of Antidepressants on Chronic Neuropathic Pain
We'll reach out to this number within 24 hrs