Efficacy and Safety of Pregabalin/Tramadol Combination Versus Pregabalin in Acute Pain of Neuropathic Origin

• Status: Not yet recruiting
• Trial end date: 2022-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Laboratorios Silanes S.A. de C.V.
• Treatments: Pregabalin; Tramadol

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.).