Efficacy and Safety of Pregabalin/Tramadol Combination Versus Pregabalin in Acute Pain of Neuropathic Origin
Condition: Neuropathic Pain
MeSH terms: Neuralgia; Acute Pain
Study type: Interventional
Phase: Phase 3

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.
    

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.
    

Intervention name(s): Pregabalin 75mg/ Tramadol 50 mg; Pregabalin 75mg
Intervention type(s): Drug; Drug
Intervention description(s): Pharmaceutical Form: Tablet Dosage: 75 mg / 50 mg Administration way: oral; Pharmaceutical Form: Capsule Dosage: 75 mg Administration way: oral
Other intervention name(s): LOBUXAL; Pregabalin
Intervention MeSH terms: Pregabalin; Tramadol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Acute pain; Neuropathic; Pregabalin; Tramadol