A Study to Investigate the Effects of a New Treatment in Patients With Chronic Pain
NCT ID: NCT02301169
Last Updated: 2017-12-28
Study Results
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View full resultsBasic Information
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COMPLETED
NA
42 participants
INTERVENTIONAL
2014-03-31
2014-11-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
DOUBLE
Study Groups
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T4P1001
Heat pain stimuli A
Video A
Administration of T4P1001 capsules
This treatment is given as add on therapy to patients' regular analgesic
Placebo
Heat pain stimuli B
Video B
Administration of placebo capsules
This treatment is given as add on therapy to patients' regular analgesic
Interventions
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Heat pain stimuli A
Video A
Administration of T4P1001 capsules
This treatment is given as add on therapy to patients' regular analgesic
Heat pain stimuli B
Video B
Administration of placebo capsules
This treatment is given as add on therapy to patients' regular analgesic
Eligibility Criteria
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Inclusion Criteria
* Body weight of more than 40 kg and less than 120 kg with a BMI between 19-31 kg/m2 inclusive
* Diagnosed with Peripheral Neuropathic Pain (PNP) since at least 6 months
* Being affiliated with the national welfare system
* Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures
* Have given written informed consent approved by the relevant Ethics Committee (EC) governing the study site
* Patient with chronic PNP supported by a distinct neuroanatomical plausible distribution with sensory signs and symptoms, and consecutive to one of the following causes: a traumatic event, a surgical procedure (excluding limb amputation), radiculopathy, post-herpetic or post-zooster neuralgia, diabetic polyneuropathy or post-anticancer chemotherapy. Diagnosis will have to be confirmed by the DN4 questionnaire at the screening visit (pain is considered as neuropathic if DN4 score ≥ 4)
* Pain present since at least 6 months
* Patients will be required to have a score between 4 and 8 inclusive on the mean Average Pain Score (APS) Numeric Rating Scale (NRS) during the baseline period preceding randomization (data collected in patient diary) and to have completed at least 4 days of pain assessment
Exclusion Criteria
* With a current or recent history, as determined by the Investigator, of severe, progressive, and/or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological, or cerebral disease which would interfere with the patient's participation in the study
* Uncontrolled epilepsy
* Any current primary psychiatric condition, including major depression or major personality disorders (such as Axe II of Diagnostic and Statistical Manual of Mental Disorders (DSM-IV); personality disorders and mental retardation)
* Alcohol dependence or regular use of known drugs of abuse (e.g., amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, methadone, opiates, and phencyclidine)
* Acute disease state within 7 days before Visit 2
* Any other relevant medical disorder likely to interfere with the trial or represent a risk for the patient
* Any close relationship with the Investigators or the Sponsor (i.e. belonging to immediate family or subordination link)
* Patient under legal protection, according to the national law
* Patient currently enrolled in a clinical trial involving use of an investigational drug or device, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study, or in an exclusion period according to national law
* Neuropathic pain due to trigeminal neuralgia, central pain, complex regional pain syndrome and phantom limb pain
* Plan to have a session of physiotherapy or comportemental therapy such as gestion of pain, hypnosis, sophrology, meditation program during the study
* Have initiated or have planned an electrical stimulation (or neurostimulation) therapy within 2 weeks prior to Visit 1 or during the study period up to Visit 5
* Patient changed his/her " regular therapy " in the last 4 months
18 Years
ALL
No
Sponsors
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Tools4Patient
OTHER
Responsible Party
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Principal Investigators
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Alvaro Pereira
Role: STUDY_DIRECTOR
Tools4Patient
Locations
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CIC Clermont-Ferrand, CHU Clermont-Ferrand
Clermont-Ferrand, , France
Countries
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Other Identifiers
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T1001-01
Identifier Type: -
Identifier Source: org_study_id