Treatment of Neuropathic Pain in Leprosy (NCT03324035) | Clinical Trial Compass
UnknownPhase 3
Treatment of Neuropathic Pain in Leprosy
Brazil102 participantsStarted 2017-03-01
Plain-language 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
Who can participate
Age range18 Years – 85 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Presence of spontaneous pain of medium intensity in the last 24 hours with a minimum value of 4 in 10 on a numerical scale, with a maximum of 10 points (summed pain questionnaire)
* Duration of pain of at least 6 months
* Presence of neuropathic pain "pure" or of clearly dominant character (no other pain, or pain associated unimportant)
* Pain due to leprosy confirmed by clinical examination and / or appropriate electrophysiological examination
* Ability to properly understand the Portuguese language, being able to understand the methodology of the study and questionnaires
* Having provided their consent in writing of their participation in the study
Exclusion Criteria:
* Linked to the disease in study:
* Neuropathic pain from other causes that not Hansen's disease (Diabetes, HIV, and after chemotherapy);
* Linked to the treatment:
* Hypersensitivity to amitriptyline and tramadol;
* Ongoing treatment with monoamine oxidase inhibitors (MAOIs);
* Cardiac and ophthalmologic disorders that contraindicate the use of amitryptiline;
* Pregnant or nursing women, or even women of childbearing age without the use of contraceptives.
* General
* Other pain with intensity higher then the neuropathic one;
* Ant other condition that may interfere with the evaluation of the study;
* Patients who have not given or signed the informed consent form;
* Incorrectly completion of the self-assessment of pain notebook in the period between inclusion and randomization (at lea…
What they're measuring
1
Reduction in pain intensity of 30% from baseline measured by verbal analog scale (VAS)