Analgesic Effect of Paracetamol in Neuropathic Pain Patients
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- Pain intensity change between period 1 and 2
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Paracetamol 500 mg capsules (Doliprane® 500 mg) will remain packaged in their blister packs of origin. The necessary quantity of capsules will be packaged in a box labelled at the corresponding period (period 1 or 2).
Lactose capsules (placebo) of the same size and colour as the Paracetamol capsules (Doliprane® 500 mg) will be bought by the CHU Pharmacy from Clermont-Ferrand. The capsules will then be blistered; the necessary quantity of capsules placebo will be packaged in the same box used for paracetamol, labelled at the time of the treatment (period 1 or 2).
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Paracetamol and placebo comparator (Group 1)
Neuropathic pain patients taking either paracetamol or placebo according to the randomization plan
干预措施: paracetamol (Drug)
Paracetamol and placebo comparator (Group 1)
Neuropathic pain patients taking either paracetamol or placebo according to the randomization plan
干预措施: Placebo comparator (Other)
Paracetamol and placebo comparator (Group 2)
Neuropathic pain patients taking either paracetamol (if during period 1 they received placebo) or placebo (if during period 1 they received paracetamol)
干预措施: paracetamol (Drug)
Paracetamol and placebo comparator (Group 2)
Neuropathic pain patients taking either paracetamol (if during period 1 they received placebo) or placebo (if during period 1 they received paracetamol)
干预措施: Placebo comparator (Other)
结局指标
主要结局
Pain intensity change between period 1 and 2
时间窗: Day 1 to Day 7 (one week) and Day 15 to Day 21 (one week).
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.
次要结局
- Treatment responders at 30% (NPRS)(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).)
- Assessment of paracetamol (and placebo) consumption(At Day1, Day8, Day15, Day22)
- Treatment responders at 50% (NPRS)(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).)
- Number of paroxysms(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).)
- Blood dosage of paracetamol and its metabolites(At Day1, Day8, Day15, Day22)
- Urinary dosage of paracetamol and its metabolites(At Day1, Day7, Day15, Day21)
- Analysis of pharmacogenetics parameters(At the pre-selection visit (Day-6).)
- Impact of paracetamol on patient feeling and satisfaction by Global Patient Impression of Change (PGIC)(At Day1, Day8, Day15, Day22)
- Paroxysms intensity (NPRS)((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).)
- Assessment of dynamic mechanical allodynia(At Day1, Day8, Day15, Day22)
- Blood dosage of glutathione(At Day-6, Day1, Day8, Day15, Day22)
- Assessment of liver and renal functions(At Day-6, Day1, Day8, Day15, Day22)
- Impact of paracetamol on cognitive parameters evaluated by Cantab® tests: Motor Screening Test (MOT), Stocking of Cambridge (SOC), Information Sampling task (IST).(At Day1, Day8, Day15, Day22)
- Emotional status by Hospital Anxiety and Depression scale (HAD)(At Day1, Day8, Day15, Day22)
- Sleep by the Pittsburgh Sleep Quality Index (PSQI)(At Day1, Day8, Day15, Day22)
- Descriptive analysis of adverse event of paracetamol use.(Pain diary: over 4 weeks: At the pre-selection visit (Day -6) to the end of the study (Day 22).)