Trial intelligence / Profile preview

Paracetamol in Neuropathic Pain

NCT03559985Phase 2

Key facts

Status
Terminated
Start
Aug 2018
Primary completion
Oct 2020
Countries
1
Modality
Small Molecules
Conditions
neuropathic pain
01

Overview

Phase 2, randomised, double-blind trial of acetaminophen in neuropathic pain (2 arms), sponsored by Centre Hospitalier Universitaire de Clermont-Ferrand. Primary endpoint: Pain intensity change between period 1 and 2. Started Aug 2018; status: terminated.

02

Design

2 arms
Study design
RandomizedDouble-blind
  • Paracetamol then Placebo

    Received Paracetamol in Period 1 and Placebo in Period 2

  • Placebo then Paracetamol

    Received Placebo in Period 1 and Paracetamol in Period 2

03

Who it enrols

Adult patients (18-65) with chronic peripheral neuropathic pain (duration > 3 months) and pain intensity >= 3 on NPRS. Patients must not be taking daily paracetamol.

04

Endpoints

Primary

  • Pain intensity change between period 1 and 2

Secondary

  • Treatment responders at 30% (NPRS)

  • Treatment responders at 50% (NPRS)

  • Number of paroxysms

  • Paroxysms intensity (NPRS)

  • Assessment of paracetamol (and placebo) consumption

  • Assessment of dynamic mechanical allodynia

  • Assessment of liver and renal functions

  • Blood dosage of glutathione

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