Status:
COMPLETED
Efficacy and Safety of Pregabalin/Tramadol Combination Versus Pregabalin in Acute Pain of Neuropathic Origin
Lead Sponsor:
Laboratorios Silanes S.A. de C.V.
Conditions:
Neuropathic Pain
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief 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...
Detailed Description
Study to evaluate the efficacy and safety of the fixed-dose combination of Pregabalin/Tramadol versus Pregabalin in the management of acute pain of neuropathic origin. Patients who meet the inclusion ...
Eligibility Criteria
Inclusion
- 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
- 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.).
Key Trial Info
Start Date :
July 11 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 25 2023
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT05324059
Start Date
July 11 2022
End Date
April 25 2023
Last Update
June 15 2023
Active Locations (1)
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1
Laboratorio Silanes, S.A. de C.V.
Mexico City, Mexico, 11000