A Phase 3 interventional study of Pregabalin 75mg/ Tramadol 50 mg and Pregabalin 75mg in Neuropathic Pain, sponsored by Laboratorios Silanes S.A. de C.V.. Completed at 1 site in Mexico. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-06-15.
Sponsored by Laboratorios Silanes S.A. de C.V. · Phase 3, Interventional, and Treatment
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 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.
1,287 studies on the registry are indexed under Neuralgia; 256 are open to participants now.
This study's enrollment of 110 is above the median of 52 across 973 interventional studies indexed under Neuralgia.
Browse Neuralgia studies →Laboratorios Silanes S.A. de C.V. is the lead sponsor of 43 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
Fixed dose combination tablet of 75 mg Pregabalin and 50 mg of Tramadol, orally, every 12 hours.
Drug: Pregabalin 75mg/ Tramadol 50 mg
Monotherapy with 75 mg of Pregabalin, orally, every 12 hours.
Drug: Pregabalin 75mg
Pharmaceutical Form: Tablet Dosage: 75 mg / 50 mg Administration way: oral
Also known as: LOBUXAL
Pharmaceutical Form: Capsule Dosage: 75 mg Administration way: oral
Also known as: Pregabalin
Proportion of subjects with a success rate of >50% in pain reduction
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.
Time frame: 15 days
Mean change in pain intensity by VAS (Visual Analog Scale)
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.
Time frame: Baseline,1,3,5,7,10, 13 and 15 days
Mean change in pain intensity by DN4 questionnaire
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.
Time frame: Baseline, 3, 10 and 15 days
Proportion of subjects requiring dose escalation
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.
Time frame: Day 3
Frequency of adverse events
Compare the frequency of adverse events presented during the study between the treatment groups.
Time frame: 15 days
Intensity of adverse events.
Compare the intensity of adverse events presented by treatment group.
Time frame: 15 days
Adherence percentage
Report the percentage of adherence to the intervention by treatment group, using the count of tablets returned to the research site
Time frame: 15 days
Plan to share: No
This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.
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Laboratorios Silanes S.A. de C.V.