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
Phase:
Phase 3
Details
Lead Sponsor:
University of Sao Paulo
Collaborator:
Cristália Produtos Químicos Farmacêuticos Ltda.
Treatments:
Amitriptyline Amitriptyline, perphenazine drug combination Tramadol