Paracetamol and Neuropathic Pain

Phase 2TerminatedNCT03559985

University Hospital, Clermont-Ferrand43 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Neuropathic Pain

Interventions

paracetamolDRUG

Period 1 (D1 to D7): 500 mg (paracetamol or placebo) to be repeated if necessary, depending on the intensity of pain, after 4 hours minimum between each treatment intake, with a maximum dose of 3 g/day, corresponding to 6 capsules per day. Wash-out period (D8 to D14): patients should not take paracetamol during this week. Period 2 (D15 to D21): 500 mg per dose (paracetamol or placebo) to be repeated if necessary, depending on the intensity of pain, after 4 hours minimum between each treatment intake, with a maximum dose of 3 g/day, corresponding to 6 capsules per day.

Placebo comparatorOTHER

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (1)

Lise LACLAUTRE

Clermont-Ferrand, France

Outcomes

Primary Outcomes

Pain intensity change between period 1 and 2

Pain intensity change between period 1 and 2, measured by numerical pain rating scale (NPRS) over one week (two evaluations per day, morning and evening) following the taking of paracetamol/ placebo.

Time frame: Day 1 to Day 7 (one week) and Day 15 to Day 21 (one week).

Secondary Outcomes

Treatment responders at 30% (NPRS)

Calculation of the decrease of NPRS by at least 30% between the beginning and the end of the treatment period (at least 30% difference between the average of four NPRS measurements over 2 days before the start of the treatment period and the average of the four NPRS measurements over 2 days at the end of the treatment period). The number of paracetamol responders will be compared to the number of placebo responders.

Time frame: 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).

Treatment responders at 50% (NPRS)

Calculation of the decrease of NPRS by at least 50% between the beginning and the end of the treatment period (at least 50% difference between the average of four NPRS measurements over 2 days before the start of the treatment period and the average of four NPRS measurements over 2 days at the end of the treatment period). The number of paracetamol responders will be compared to the number of placebo responders.

Number of paroxysms

The number of paroxysms will be listed by the patient in the daily pain diary during all the study (28 days).

Time frame: 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).

Data from ClinicalTrials.gov

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