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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
42
This treatment is given as add on therapy to patients' regular analgesic
CIC Clermont-Ferrand, CHU Clermont-Ferrand
Clermont-Ferrand, France
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
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
Time frame: Time zero equals baseline (Day 1) up to Day 42
Patient 's Change From Baseline of Pain Severity as Measured by the Weekly Means of the Daily Worst Pain Scores (WPS)
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
Time frame: Time zero equals baseline (Day 1) up to Day 42
Patient's Change From Baseline of Investigator Global Assessment of Change (IGAC)
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.
Time frame: Time zero equals baseline (Day 1) up to Day 28
Patient's Change of Pain Intensity After Heat Pain Stimuli From Baseline to End of Treatment Period
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.
Time frame: Time zero equals baseline (Day 1) up to Day 28
Patient 's Change From Baseline of Pain Severity as Measured by the Weekly Means of the Brief Pain Inventory (BPI).
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
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This treatment is given as add on therapy to patients' regular analgesic
Time frame: Time zero equals baseline (Day 1) up to Day 28