NCT03559985

Paracetamol and Neuropathic Pain

Analgesic Effect of Paracetamol in Neuropathic Pain Patients

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: University Hospital, Clermont-Ferrand · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Neuropathic Pain

Interventions

Type	Name	Description
DRUG	paracetamol	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.
OTHER	Placebo comparator	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.

Timeline

• Start date: 2018-08-20
• Primary completion: 2020-10-08
• Completion: 2022-08-31
• First posted: 2018-06-18
• Last updated: 2022-10-10

Locations

1 site across 1 country: France