Clinical trial NCT03559985: Paracetamol and Neuropathic Pain
Official title: Analgesic Effect of Paracetamol in Neuropathic Pain Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Neuropathic Pain
Keywords: Paracetamol
Neuropathic pain
Analgesic effect
Pharmacogenetics
Biological parameters
Cognitivo-emotional parameters
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2018-06-18
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: After a week of pre-selection (D-6 to D0), each patient will receive successively in random order each of the 2 products (paracetamol and placebo) with one wash-out period of 7 days between each administration.
Primary purpose: TREATMENT

Brief summary: The aim of this study is to evaluate the analgesic effect of paracetamol in patients suffering from pain with a peripheral neuropathic component in the presence of their usual treatment.

Detailed description: This is an interventional, randomized, placebo-controlled, double-blind, crossover study about the use of paracetamol in therapeutic doses in peripheral neuropathic pain patients. The analgesic effect of paracetamol will be assessed by the painful intensity measured by numerical pain rating scale over one week after taking paracetamol/placebo.

The secondary objectives will be:

* To determine the number of patients in whom paracetamol is effective in reducing pain by at least 30% and 50%,
* To evaluate the effect of paracetamol on pain, on the number and intensity of paroxysms,
* To evaluate paracetamol consumption,
* To evaluate the effect of paracetamol on neuropathic pain patient,
* To evaluate the effect of paracetamol on mechanical allodynia,
* To monitor routine biological parameters (liver function),
* Compare Glutathione (GSH) concentrations before and after taking paracetamol,
* To perform a blood test for paracetamol and its metabolites before and after each study period,
* To perform urine dosage of paracetamol and its metabolites before and after each study period,
* To study pharmacogenetics parameters,
* To evaluate patient feeling and satisfaction after taking paracetamol,
* To evaluate the effect of paracetamol on cognition, anxiety, depression and sleep by different questionnaires,
* To collect adverse events.

Eligibility criteria: Inclusion Criteria:

* Patient aged 18 to 65 years,
* Patient suffering from chronic pain (for more than 3 months) with the characteristics of peripheral neuropathy and having pain assessed by a numerical scale ≥ 3 for one week, with at least 10 assessments completed,
* Patient agrees with not to take paracetamol, other than the treatment provided as part of the protocol, from inclusion to completion of the study,
* Acceptance to give a written consent.

Exclusion Criteria:

* Patient taking paracetamol daily,
* Patient with a contraindication to paracetamol administration (liver or renal failure, ...),
* Patient with a biological evaluation evaluated by the investigator as not compatible with the trial,
* Patient with a medical and/or surgical history evaluated by the investigator to be not compatible with the trial,
* Patient with drug treatments evaluated by the investigator to be not compatible with the trial,
* Pregnant or nursing woman,
* Patient with a cooperation and an understanding that does not allow for a strict compliance under the conditions set out in the protocol,
* Patient participating in another clinical trial, or being in an exclusion period, or having received a total amount of compensation exceeding 4500 euros over the 12 months preceding the start of the trial,
* Patient benefiting from a legal protection measure (curatorship, guardianship, protection of justice...),
* Patient not affiliated to the French Social Security system,
* Paracetamol intake during wash-out period.

Primary outcomes:
measure: Pain intensity change between period 1 and 2
timeFrame: Day 1 to Day 7 (one week) and Day 15 to Day 21 (one week).
Secondary outcomes:
measure: Treatment responders at 30% (NPRS)
timeFrame: During 2 days before period 1 (mean of Day -1 and Day 0) and at the end of period 1 (mean of Day 6 and Day 7); during 2 days before period 2 (mean of Day 13 and Day 14) and at the end of period 2 (mean of Day 20 and Day 21).
measure: Treatment responders at 50% (NPRS)
timeFrame: During 2 days before period 1 (mean of Day -1 and Day 0) and at the end of period 1 (mean of Day 6 and Day 7); during 2 days before period 2 (mean of Day 13 and Day 14) and at the end of period 2 (mean of Day 20 and Day 21).
measure: Number of paroxysms
timeFrame: Before period 1 (Day -6 to Day 0), over a week during period 1 (Day 1 to Day 7), over a week during wash-out (Day 8 to Day 14) and over a week during period 2 (Day 15 to Day 21).
measure: Paroxysms intensity (NPRS)
timeFrame: (Day -6 to Day 0), over a week during period 1 (Day 1 to Day 7), over a week during wash-out (Day 8 to Day 14) and over a week during period 2 (Day 15 to Day 21).
measure: Assessment of paracetamol (and placebo) consumption
timeFrame: At Day1, Day8, Day15, Day22
measure: Assessment of dynamic mechanical allodynia
timeFrame: At Day1, Day8, Day15, Day22
measure: Assessment of liver and renal functions
timeFrame: At Day-6, Day1, Day8, Day15, Day22
measure: Blood dosage of glutathione
timeFrame: At Day-6, Day1, Day8, Day15, Day22
measure: Blood dosage of paracetamol and its metabolites
timeFrame: At Day1, Day8, Day15, Day22
measure: Urinary dosage of paracetamol and its metabolites
timeFrame: At Day1, Day7, Day15, Day21
measure: Analysis of pharmacogenetics parameters
timeFrame: At the pre-selection visit (Day-6).
measure: Impact of paracetamol on patient feeling and satisfaction by Global Patient Impression of Change (PGIC)
timeFrame: At Day1, Day8, Day15, Day22
measure: Impact of paracetamol on cognitive parameters evaluated by Cantab® tests: Motor Screening Test (MOT), Stocking of Cambridge (SOC), Information Sampling task (IST).
timeFrame: At Day1, Day8, Day15, Day22
measure: Emotional status by Hospital Anxiety and Depression scale (HAD)
timeFrame: At Day1, Day8, Day15, Day22
measure: Sleep by the Pittsburgh Sleep Quality Index (PSQI)
timeFrame: At Day1, Day8, Day15, Day22
measure: Descriptive analysis of adverse event of paracetamol use.
timeFrame: Pain diary: over 4 weeks: At the pre-selection visit (Day -6) to the end of the study (Day 22).
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: Lise LACLAUTRE
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Gisèle PICKERING
role: PRINCIPAL_INVESTIGATOR
References: