Status:
COMPLETED
Effectiveness and Safety of Methadone Versus Placebo for the Control of Neuropathic Pain in Different Etiologies
Lead Sponsor:
University of Sao Paulo
Conditions:
Neuropathic Pain
Eligibility:
All Genders
18-85 years
Phase:
PHASE3
Brief 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 sa...
Detailed Description
Background: neuropathic pain (NP) is highly refractory and it is estimated that about 40% of patients remain symptomatic despite the use of first and second line drugs. Opioids are currently ranked as...
Eligibility Criteria
Inclusion
- Presence of an exclusive neuropathic pain (without other main pain syndrome occurring concomitantly at the same body area);
- Pain lasting at least 6 months (chronic) and being present most of the days;
- Pain fulfilling the current IASP (The International Association for the Study of Pain) criteria for defined Neuropathic Pain and with a score on the DN4 questionnaire (Douleur Neuropathique Pain 4 Questions) ≥ 4 (positive);
- The pain must be of at least moderate intensity (score on a visual analogue pain scale ≥ 40/100) despite the use of first and second line drugs in an adequate dosing.
Exclusion
- Patients under the age of 18 or over 85;
- Who has neuropathic pain duration less than 6 months;
- Who do not have an exclusive neuropathic pain (without other main pain syndrome occurring concomitantly at the same body area);
- Patients with neuropathic pain intensity less than 40 out of 100 on a visual analogue pain scale;
- Who scored less than 4 on the DN4 scale;
- Who wishes at any time to abandon the study;
- Patients with a previous allergic reaction to any of the drugs involved in the study (methadone) or placebo components;
- Patients in current use or in the last 14 days of medication (s) inhibitor (s) of monoamine oxidase (MAOI) or other medications with potential drug interaction with methadone;
- Patients in current continuous use of opioids (including methadone);
- Patients with a history of opioid abuse;
- Patients with a history of heavy/abusive alcohol consumption;
- Who is under judicial litigation, police custody or institutionalized for other reasons;
- Pregnant women, lactating women or women of childbearing age (without the use of an adequate contraceptive method);
- Patients with participation in another research protocol that implies the use of some medication during the 30 days preceding the inclusion in the project;
- Who uses illegal drugs;
- Patients unable to assess the risks and benefits of participating in the present study (eg, language barriers, psychiatric disorders or cognitive impairment);
- The presence of psychiatric disorders such as uncontrolled posttraumatic stress disorder, uncontrolled depression, uncontrolled anxiety disorder and suicidal ideation;
- Who has acute or chronic renal failure;
- Who has liver or heart failure;
- Who has a history of elevated cardiac QT interval, risk factors for elevated QT interval (including drugs that can prolong that interval), as well as cardiac arrhythmias/cardiac conduction abnormalities;
- Who has serious or intolerable adverse reactions to any component of the drugs involved in the study;
- Patients with a previous history of severe asthma or severe respiratory disease that may increase the risk of respiratory failure;
- Patients with active infectious gastrointestinal disease, active inflammatory gastrointestinal disease and obstruction of the gastrointestinal tract;
- Patients with history of recent traumatic brain injury (less than 7 days) or severe at any time interval;
- Who has moderate or severe obstructive sleep apnea-hypopnea syndrome;
- Who has uncontrolled hypothyroidism or hyperthyroidism;
- Patients with a history of uncontrolled epilepsy;
- Patients with current intracranial hypertension;
- Patients with grade III obesity (BMI ≥ 40 kg / m2).
Key Trial Info
Start Date :
September 6 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 20 2023
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT05235191
Start Date
September 6 2019
End Date
January 20 2023
Last Update
February 8 2023
Active Locations (1)
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1
University of São Paulo
São Paulo, Brazil, 05403-000