Confirmatory Study of Efficacy and Safety of the Pregabalin/Tramadol Combination Versus Pregabalin in the Management of Acute Pain of Neuropathic Origin.

SIL-30901-III-21 (2)

Phase IIIb confirmatory study of efficacy and safety, longitudinal, multicenter, randomized, double-blind study of the combination Pregabalin/Tramadol versus Pregabalin in the management of acute pain of neuropathic origin.

2022-07-11

2023-04-18

2023-04-25

Completed

Early phase I

110

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.).

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2023-06-15