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 @ 2:45 PM
Ignite Modification Date:
2025-12-24 @ 2:45 PM
NCT ID:
NCT05324059
Eligibility Criteria:
Inclusion Criteria:
* Any gender.
* That the subject agrees to participate in the study and give its informed consent in writing.
* Age \>18 years and ≤65 years of age at the start of the study.
* Neuropathic Pain Questionnaire (DN4) ≥ 4.
* Patients with proven tolerability (absence of moderate-serious adverse events) to pregabalin, defined by consumption of pregabalin 50 mg/day for 3 days.
* Women of childbearing age who have an acceptable method of contraception (eg barrier, oral hormonal, injectable, subdermal).
Exclusion Criteria:
* Contraindication and known hypersensitivity to the use of pregabalin and/or tramadol.
* The patient is participating in another clinical study involving an investigational treatment or participated in any in the previous 4 weeks.
* In the medical opinion, a disease that affects the prognosis and prevents outpatient management, for example, but not limited or restricted to: terminal cancer, heart failure, obstruction gastrointestinal including paralytic ileus, suspected surgical abdomen, respiratory failure with scheduled surgical or hospital procedures.
* Positive pregnancy test, women who are pregnant, nursing or planning a pregnancy during the conduct of the study.
* Patients with a diagnosis of respiratory diseases: status asthmaticus, asthma, chronic obstructive pulmonary disease (COPD), cor pulmonale, acute respiratory depression, hypercapnia.
* Patients who are receiving monoamine oxidase inhibitors (MAOIs) or who have received within the last 2 weeks.
* Patients with a history of seizure disorders, epileptic status, and grand mal seizures.
* Patients with a history of severe depression of the central nervous system due to consumption of opiates.
* History of acute intoxications with hypnotics, opioid analgesics and psychotropics.
* History of alcohol or drug abuse (including opiates) in the last year according to DSM-V.
* Patients with a history of severe head trauma and/or brain edema.
* History/presence of any disease or condition which, in the opinion of the Investigator, could pose a risk to the patient or confound the efficacy and safety results of the study.
* Patients with symptoms suggestive of active COVID-19 infection (i.e., fever, cough, dyspnea) and/or contact in the last 14 days with a suspected or positive patient for COVID-19.
* Patients whose participation in the study may be influenced (employment relationship with the center investigator or sponsor, inmates, etc.).
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT05324059
Study Brief:
Protocol Section:
NCT05324059