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Effectiveness and Safety of Methadone Versus Placebo for the Control of Neuropathic Pain in Different Etiologies

NCT05235191 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2023-02-08

No results posted yet for this study

Summary

Opioids are currently ranked as third-line agents for neuropathic pain (NP) treatment. The opioids more frequently tested for NP were tramadol, oxycodone and morphine. In the present study test the safety and effectiveness of methadone in patients with NP who remain symptomatic despite the use of first and second line drugs in a placebo-controlled randomized approach.

Conditions

  • Neuropathic Pain

Interventions

DRUG

methadone tablets

The intervention with the active drug (methadone) will start with the dose of 1 tablet (5 mg) twice a day (every 12 hours) and titrated on subsequent visits up to the maximum dose of 6 tablets a day (totaling 30 mg divided into 2 daily doses to facilitate therapeutic adherence).

DRUG

Placebo

In this arm patients will take placebo tablets (the same number, color and physical aspects as the methadone tablets).

Sponsors & Collaborators

  • University of Sao Paulo

    lead OTHER

Principal Investigators

  • Daniel C. de Andrade, PhD · University of Sao Paulo

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2019-09-06
Primary Completion
2023-01-20
Completion
2023-01-20

Countries

  • Brazil

Study Locations

More Related Trials

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 NCT05235191 on ClinicalTrials.gov