drugset / Trial / NCT03324035

Treatment of Neuropathic Pain in Leprosy

NCT03324035

RandomizedParallel-groupQuadruple-blindTreatment

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

Timeline

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

Drugs

EvaluationDrugModalityDoseRoute
Subject Amitriptyline Small molecule 25 mg
Subject Amitriptyline Small molecule 50 mg
Subject Amitriptyline Small molecule 75 mg
Background Tramadol Other / unclassified 50 mg