Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:23 PM
Ignite Modification Date:
2025-12-24 @ 10:23 PM
NCT ID:
NCT03324035
Eligibility Criteria:
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 least 4 scores in 7 days);
* Patients who can't be followed on a regular basis or that miss the appointments (we will give a 7 day tolerance for each appointment);
* Documented abuse of psychoactive drugs or alcohol;
* History of past or actual psychosis;
* Actual diagnosis of major depression following the DSM-IV criteria;
* Language and cognitive deficits that are capable of interfering with the understanding of the study;
* Patients not affiliated with a social security scheme (beneficiary or recipient);
* Patients who refuses to sign or are unable to understand the informed consent, under guardianship;
* Participation in other research protocol involving the use of any medication during the 30 days preceding the inclusion in the project.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT03324035
Study Brief:
Protocol Section:
NCT03324035