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

June 12, 2023 updated by: Laboratorios Silanes S.A. de C.V.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 criteria of the protocol and start treatment with the combination Pregabalin / Tramadol (75 mg / 50 mg) or Pregabalin 75 mg will be included. To evaluate the proportion of subjects who reported a success rate in the reduction of pain by 50%, the percentage of change in the pain intensity reported through the Visual Analog Pain Scale (VAS) will be calculated. This percentage will be categorized and the proportion of patients per treatment group will quantify. Changes in pain intensity during the intervention will be evaluated with the fixed-dose combination of Pregabalin/Tramadol (75 mg / 50 mg) or Pregabalin 75 mg, comparing the average difference in pain reported through VAS at days 1, 3, 5, 7, 10, 13 and 15 with respect to their baseline measurement. The mean change in reported neuropathic pain intensity across the DN4 questionnaire will also be evaluated, comparing its measurement on day 3, 10 and 15 with respect to the baseline, in each treatment group.

At visit 1 (day 3) the need for dose escalation will be evaluated (Pregabalin/Tramadol (150 mg / 50 mg) or pregabalin (150 mg)) in both treatment groups, continuing with its follow-up in the evaluation of the intensity of pain reported by EVA and DN4. The proportion of subjects who started on the dose of Pregabalin / Tramadol (75 mg / 50 mg) or Pregabalin 75 mg, those that required adjustment of dose to treatment (Pregabalin / Tramadol (150 mg / 50 mg) or Pregabalin (75 mg)), as well as the proportion of patients who suspended the treatment.

The percentage of adherence to the intervention by treatment group will be reported.

The proportion of adverse events presented during the conduct of the study will be evaluated, regardless of the dose administered, to all the subjects who have received at least one dose of the investigational drug Which will be reported be reported through frequencies and percentages and classified according to frequency, gravity, severity (intensity) and the causality of the clinical manifestation.

Study Type

Interventional

Enrollment (Actual)

110

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Mexico
      • Ciudad de México, Mexico, 11000
        • Laboratorio Silanes, S.A. de C.V.
        • Contact:
        • Contact:
        • Principal Investigator:
          • Rodrigo Suárez Otero, M.D.
        • Principal Investigator:
          • Isabel E Rucker, M.D.
        • Principal Investigator:
          • Luis R Partida, M.D.
        • Principal Investigator:
          • Alfonso Hernández Zepeda, M.D.
        • Principal Investigator:
          • Ma. Dolores Alonso Matínez, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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.).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A: Pregabalin/Tramadol
Fixed dose combination tablet of 75 mg Pregabalin and 50 mg of Tramadol, orally, every 12 hours.
Drug: Pregabalin 75mg/ Tramadol 50 mg
Pharmaceutical Form: Tablet Dosage: 75 mg / 50 mg Administration way: oral
Other Names:
  • LOBUXAL
Active Comparator: Group B: Pregabalin
Monotherapy with 75 mg of Pregabalin, orally, every 12 hours.
Drug: Pregabalin 75mg
Pharmaceutical Form: Capsule Dosage: 75 mg Administration way: oral
Other Names:
  • Pregabalin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of subjects with a success rate of >50% in pain reduction
Time Frame: 15 days
Evaluate the proportion of subjects who reported a success rate of >50% in pain reduction at completion of the intervention, measure by the VAS (Visual Analog Scale) per treatment group. In a straight 10 centimeter line in which one end means no pain and the other end means the worst pain imaginable, the participants mark the amount of pain feeling at that moment.
15 days
Mean change in pain intensity by VAS (Visual Analog Scale)
Time Frame: Baseline,1,3,5,7,10, 13 and 15 days
Evaluate the mean change in pain intensity reported on days 1, 3, 5, 7, 10, 13, and 15 with respect to its baseline measurement, reported through the VAS (Visual Analog Scale) per treatment group. In a straight 10 centimeter line in which one end means no pain and the other end means the worst pain imaginable, the participants mark the amount of pain feeling at that moment.
Baseline,1,3,5,7,10, 13 and 15 days
Mean change in pain intensity by DN4 questionnaire
Time Frame: Baseline, 3, 10 and 15 days
Evaluate the mean change in pain intensity reported on days 3, 10 and 15 with respect to its baseline measurement according to the DN4 Questionnaire by treatment group.
Baseline, 3, 10 and 15 days
Proportion of subjects requiring dose escalation
Time Frame: Day 3
Evaluate the proportion of subjects who required dose escalation (from Pregabalin/Tramadol 75mg/50 to 150 mg/ 50 mg or Pregabalin 75mg to 150 mg, as appropriate) during the intervention, by treatment group.
Day 3
Frequency of adverse events
Time Frame: 15 days
Compare the frequency of adverse events presented during the study between the treatment groups.
15 days
Intensity of adverse events.
Time Frame: 15 days
Compare the intensity of adverse events presented by treatment group.
15 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adherence percentage
Time Frame: 15 days
Report the percentage of adherence to the intervention by treatment group, using the count of tablets returned to the research site
15 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Laboratorios Silanes S.A. de C.V.

Investigators

  • Principal Investigator: Rodrigo Suárez Otero, M.D, Independent consultant
  • Principal Investigator: Isabel E Rucker, M.D, Clinical Research Institute
  • Principal Investigator: Luis R Partida, M.D, Investigación Biomédica para el Desarrollo de Fármacos S.A. de C.V.
  • Principal Investigator: Alfonso Hernández Zepeda, M.D, IMACEN S.A. de C.V.
  • Principal Investigator: Ma. Dolores Alonso Martínez, M.D, CICMEX, Centro de Investigación Clínica de México S. de R.L de C.V.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 11, 2022

Primary Completion (Actual)

April 18, 2023

Study Completion (Actual)

April 25, 2023

Study Registration Dates

First Submitted

April 4, 2022

First Submitted That Met QC Criteria

April 4, 2022

First Posted (Actual)

April 12, 2022

Study Record Updates

Last Update Posted (Actual)

June 15, 2023

Last Update Submitted That Met QC Criteria

June 12, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SIL-30901-III-21 (2)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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