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A Study to Investigate the Effects of a New Treatment in Patients With Chronic Pain

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ClinicalTrials.gov Identifier: NCT02301169
Recruitment Status : Completed
First Posted : November 25, 2014
Results First Posted : May 16, 2016
Last Update Posted : December 28, 2017
Sponsor:
Information provided by (Responsible Party):
Tools4Patient

Brief Summary:
The purpose of this clinical trial conducted in patients suffering from chronic pain is to study the relationship between individual patients' profile and their analgesic response.

Condition or disease Intervention/treatment Phase
Peripheral Neuropathies Behavioral: Heat pain stimuli A Behavioral: Video A Drug: Administration of T4P1001 capsules Behavioral: Heat pain stimuli B Behavioral: Video B Drug: Administration of placebo capsules Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: A Study to Investigate the Effects of T4P1001 Treatment in Patients With Peripheral Neuropathic Pain
Study Start Date : March 2014
Actual Primary Completion Date : November 2014
Actual Study Completion Date : November 2014

Arm Intervention/treatment
Active Comparator: T4P1001 Behavioral: Heat pain stimuli A
Behavioral: Video A
Drug: Administration of T4P1001 capsules
This treatment is given as add on therapy to patients' regular analgesic

Sham Comparator: Placebo Behavioral: Heat pain stimuli B
Behavioral: Video B
Drug: Administration of placebo capsules
This treatment is given as add on therapy to patients' regular analgesic




Primary Outcome Measures :
  1. Patient 's Change From Baseline of Pain Severity as Measured by the Weekly Means of the Daily Average Pain Scores (APS) During 4 Weeks of Treatment [ Time Frame: Time zero equals baseline (Day 1) up to Day 42 ]
    11-point Numeric Rating Scale (NRS). Scale from 0 to 10, 0 meaning no pain, 10 pain as bad as you can imagine. Lower values represent a better outcome. Unit: arithmetic average of 7 days of a 11-point NRS


Secondary Outcome Measures :
  1. Patient 's Change From Baseline of Pain Severity as Measured by the Weekly Means of the Daily Worst Pain Scores (WPS) [ Time Frame: Time zero equals baseline (Day 1) up to Day 42 ]
    11-point Numeric Rating Scale (NRS) Scale from 0 to 10, 0 meaning no pain, 10 pain as bad as you can imagine. Lower values represent a better outcome. Unit: arithmetic average of 7 days of a 11-point NRS

  2. Patient's Change From Baseline of Investigator Global Assessment of Change (IGAC) [ Time Frame: Time zero equals baseline (Day 1) up to Day 28 ]
    IGAC is an investigator subjective evaluation of patient condition using a NRS from 0 to 10 with 0 meaning best and 10 worst Lower values represent a better outcome.

  3. Patient's Change of Pain Intensity After Heat Pain Stimuli From Baseline to End of Treatment Period [ Time Frame: Time zero equals baseline (Day 1) up to Day 28 ]
    11-point Numeric Rating Scale (NRS) from 0 to 10; 0 meaning no pain, 10 pain as bad as you can imagine Lower values represent a better outcome Unit: arithmetic average on 6 reported scores per Visit.

  4. Patient 's Change From Baseline of Pain Severity as Measured by the Weekly Means of the Brief Pain Inventory (BPI). [ Time Frame: Time zero equals baseline (Day 1) up to Day 28 ]

    Arithmetic average of 3 questions on an 11-point Numeric Rating Scale (NRS) from 0 to 10, 0 meaning no pain, 10 pain as bad as you can imagine.

    Lower values represent a better outcome




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men or women of at least 18 years of age
  • 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

PNP disease diagnosis inclusion criteria:

  • 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:

  • Pregnant, breastfeeding, or willing to be pregnant within 2 months
  • 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

Exclusion criteria related to PNP:

  • 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

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): NCT02301169


Locations
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France
CIC Clermont-Ferrand, CHU Clermont-Ferrand
Clermont-Ferrand, France, 63003
Sponsors and Collaborators
Tools4Patient
Investigators
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Study Director: Alvaro Pereira Tools4Patient

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Responsible Party: Tools4Patient
ClinicalTrials.gov Identifier: NCT02301169     History of Changes
Other Study ID Numbers: T1001-01
First Posted: November 25, 2014    Key Record Dates
Results First Posted: May 16, 2016
Last Update Posted: December 28, 2017
Last Verified: December 2017

Keywords provided by Tools4Patient:
Pain

Additional relevant MeSH terms:
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Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases