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Treatment of Neuropathic Pain in Leprosy

NCT03324035 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 102

Last updated 2022-02-23

No results posted yet for this study

Summary

Despite large efforts to eradicate leprosy, this curable mycobacterial infection still affects 250,000 new individuals annually. Half of the globe's leprosy patients live in Brazil and India. In 2013, 33,033 new leprosy cases diagnosed in Brazil, with an average incidence of 1.05 cases / 10 000 inhabitants. Recently a new concept of care after cure has called attention for severe pain in previously treated patients, particularly, neuropathic pain. Even so, until now no single drug has been studied for the treatment of pain in this patients, and the use of drugs is based on the study of other diseases. We designed the first placebo-controlled, double blinded randomized trial in the use of flexible-dose amitriptyline (tricyclic antidepressant) for the treatment of neuropathic pain related to leprosy

Conditions

  • Pain, Neuropathic
  • Leprosy
  • Leprosy Neuropathy
  • Amitriptyline

Interventions

DRUG

Amitriptyline

Administer amitriptyline on flexible doses variating from 25mg to 75mg, with backup of tramadol, and evaluate the reduction of the pain based on the Brief Pain Inventory Questionnaire.

DRUG

Placebo oral capsule

Administer amitriptyline on flexible doses variating from 1 to 3 capsules, with backup of tramadol, and evaluate the reduction of the pain based on the Brief Pain Inventory Questionnaire.

DRUG

Tramadol

Administer to both arms on "as needed" scheme, to a maximum of 150mg/day.

Sponsors & Collaborators

  • Cristália Produtos Químicos Farmacêuticos Ltda.

    collaborator INDUSTRY

  • University of Sao Paulo

    lead OTHER

Principal Investigators

  • Daniel Andrade, PhD · University of Sao Paulo

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2017-03-01
Primary Completion
2021-05-03
Completion
2022-08-01

Countries

  • Brazil

Study Locations

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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 NCT03324035 on ClinicalTrials.gov