Trial · NCT06383702
A Study to Evaluate Pregabalin in Painful Diabetic Peripheral Neuropathy
NCT06383702, Phase 3, Unknown, CSPC Ouyi Pharmaceutical Co., Ltd.
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. A Study to Evaluate Pregabalin in Painful Diabetic Peripheral Neuropathy. Trials, record NCT06383702. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06383702
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate Pregabalin in Painful Diabetic Peripheral Neuropathy
- NCT number
- NCT06383702
- Status
- Unknown
- Phases
- Phase 3
- Enrollment
- 358 participants, estimated
- Lead sponsor
- CSPC Ouyi Pharmaceutical Co., Ltd.
- Conditions
- Painful Diabetic Neuropathy
- Interventions
- pregabalin sustained-release tablets, Placebo
- First posted
- 2024-04-25
- Last updated
- 2024-04-30
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Numeric Rating Scale (NRS) mean change at week 13. | Week 13 | The NRS is an 11-point scale ranging from zero ("no pain") to ten ("pain as bad as you can imagine") for self-reporting of pain by patients. Change from baseline in weekly mean of NRS (numeric rating scale) at week 13 will be recorded |
| Secondary | NRS mean change at Weeks 1-12 and 14 | Weeks 1-12 and 14 | The NRS is an 11-point scale ranging from zero ("no pain") to ten ("pain as bad as you can imagine") for self-reporting of pain by patients. Change from baseline in weekly mean NRS pain score at Weeks 1-12 and 14 during the treatment period will be recorded; |
| Secondary | Proportion of subjects with NRS change | Week 13 | The NRS is an 11-point scale ranging from zero ("no pain") to ten ("pain as bad as you can imagine") for self-reporting of pain by patients. Proportion of subjects with ≥ 50% and ≥ 30% change from baseline in weekly mean NRS pain score at Week 13 will be recorded; |
| Secondary | Brief McGill Pain Questionnaire (SF-MPQ) score | Weeks 1, 5, 9, 13, and 14 | It is a self-report questionnaire that allows individuals to give their doctor a good description of the quality and intensity of pain that they are experiencing. Users first select a single word from each group that best reflects their pain; then respondents specify their level of pain by indicating a position along a continuous line between two end-points; then subjects chose the numer best represent their current pain intensity (0\~5). Change from baseline in SF-MPQ (Brief McGill Pain Questionnaire) total score and each subscale Pain Grading Index (PRI), Visual Analogue Scale (VAS), and Present Pain Intensity (PPI) scores at Weeks 1, 5, 9, 13, and 14 after treatment; |
| Secondary | Medical Outcomes Study Sleep Scale (MOS-SS) score | Weeks 1, 5, 9, 13, and 14 | Participants answered a series of 12 questions assessing sleep, with values ranging from 1 to 6, and an additional dichotomous indicator of optimal sleep. All items are scored so that a high score reflects more of the attribute implied by the scale name. Each item is then converted to a 0 to 100 possible range so that the lowest and highest possible scores are set at 0 and 100, respectively. In this format, scores represent the achieved percentage of the total possible score. Change from baseline in MOS-SS sleep scale score and each subscale (sleep interference, sleep adequacy, daytime mental status, snoring, shortness of breath upon awakening, and sleep volume) score at Weeks 1, 5, 9, 13, and 14 after treatment; |
| Secondary | Hospital Anxiety and Depression Scale (HADS) score | Weeks 1, 5, 9, 13, and 14 | The HADS is a fourteen-item scale that generates ordinal data. Seven of the items relate to anxiety and seven relate to depression. Change from baseline in HADS (Hospital Anxiety and Depression Scale) score at Weeks 1, 5, 9, 13, and 14 after treatment; |
| Secondary | Patient Global Impression of Improvement (PGIC) score | Weeks 1, 5, 9, 13, and 14 | The Patient Global Impression of Change (PGIC) is a patient-reported instrument that measures change in overall status on a scale ranging from one ("very much improved") to seven ("very much worse"). The PGIC is based on the validated Clinical Global Impression of Change scale. Change from baseline in PGIC (Patient Global Impression of Improvement) score at Weeks 1, 5, 9, 13, 14 after treatment will be recorded; |
| Secondary | Clinical Global Impression of Improvement (CGIC) score | Weeks 1, 5, 9, 13, and 14 | The Clinical Global Impression of Change (PGIC) is a clinician-reported instrument that measures change in overall status on a scale ranging from one ("very much improved") to seven ("very much worse"). Change from baseline in CGIC (Clinical Global Impression of Improvement) score at Weeks 1, 5, 9, 13, 14 after treatment; |
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.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT06383702
GET https://conductscience.org/api/trials/v1/NCT06383702/registered