Trial · NCT05324059
Efficacy and Safety of Pregabalin/Tramadol Combination Versus Pregabalin in Acute Pain of Neuropathic Origin
NCT05324059, Phase 3, Completed, Laboratorios Silanes S.A. de C.V.
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Efficacy and Safety of Pregabalin/Tramadol Combination Versus Pregabalin in Acute Pain of Neuropathic Origin. Trials, record NCT05324059. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05324059
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Pregabalin/Tramadol Combination Versus Pregabalin in Acute Pain of Neuropathic Origin
- NCT number
- NCT05324059
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 110 participants, actual
- Lead sponsor
- Laboratorios Silanes S.A. de C.V.
- Conditions
- Neuropathic Pain
- Interventions
- Pregabalin 75mg/ Tramadol 50 mg, Pregabalin 75mg
- First posted
- 2022-04-12
- Last updated
- 2023-06-15
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of subjects with a success rate of >50% in pain reduction | 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. |
| Primary | Mean change in pain intensity by VAS (Visual Analog Scale) | 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. |
| Primary | Mean change in pain intensity by DN4 questionnaire | 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. |
| Primary | Proportion of subjects requiring dose escalation | 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. |
| Primary | Frequency of adverse events | 15 days | Compare the frequency of adverse events presented during the study between the treatment groups. |
| Primary | Intensity of adverse events. | 15 days | Compare the intensity of adverse events presented by treatment group. |
| Secondary | Adherence percentage | 15 days | Report the percentage of adherence to the intervention by treatment group, using the count of tablets returned to the research site |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers20
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05324059
GET https://conductscience.org/api/trials/v1/NCT05324059/registered