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Paracetamol and Neuropathic Pain

NCT03559985 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2022-10-10

No results posted yet for this study

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.

Conditions

  • Neuropathic Pain

Interventions

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.

Sponsors & Collaborators

  • University Hospital, Clermont-Ferrand

    lead OTHER

Principal Investigators

  • Gisèle PICKERING · University Hospital, Clermont-Ferrand

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-20
Primary Completion
2020-10-08
Completion
2022-08-31

Countries

  • France

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03559985 on ClinicalTrials.gov