Trial · NCT00553280
A Long-Term Study To Evaluate Safety And Efficacy Of Pregabalin For Pain Associated With Diabetic Peripheral Neuropathy
NCT00553280, Phase 3, Completed, Pfizer's Upjohn has merged with Mylan to form Viatris Inc.; results first posted 2011-01-05
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Long-Term Study To Evaluate Safety And Efficacy Of Pregabalin For Pain Associated With Diabetic Peripheral Neuropathy. Trials, record NCT00553280. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00553280
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Long-Term Study To Evaluate Safety And Efficacy Of Pregabalin For Pain Associated With Diabetic Peripheral Neuropathy
- NCT number
- NCT00553280
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 123 participants, actual
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Conditions
- Diabetic Neuropathy, Painful
- Interventions
- pregabalin
- First posted
- 2007-11-05
- Last updated
- 2021-01-25
- Results first posted
- 2011-01-05
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Summary of Adverse Events | 53 weeks | Number of participants with all causality adverse events, serious adverse events, severe adverse events, adverse events resulted in discontinuation, dose reduced or temporary discontinuation. Participants are counted only once per treatment in each row. |
| Secondary | Change From Baseline in Short-Form McGill Pain Questionnaire: Sensory Scores | From baseline to 52 weeks or study discontinuation (Study Endpoint) | The mean change from baseline in Short-Form McGill Pain Questionnaire Scores at study endpoint. Sensory score ranges from 0-33. Higher scores indicate more severe pain. |
| Secondary | Change From Baseline in Short-Form McGill Pain Questionnaire: Affective Scores | From baseline to 52 weeks or study discontinuation (Study Endpoint) | The mean change from baseline in Short-Form McGill Pain Questionnaire Scores at study endpoint. Affective score ranges from 0-12. Higher scores indicate more severe pain. |
| Secondary | Change From Baseline in Short-Form McGill Pain Questionnaire: Total Scores | From baseline to 52 weeks or study discontinuation (Study Endpoint) | The mean change from baseline in Short-Form McGill Pain Questionnaire Scores at study endpoint. Total score ranges from 0-45. Higher scores indicate more severe pain. |
| Secondary | Change From Baseline in Short-Form McGill Pain Questionnaire: Visual Analogue Scale Scores | From baseline to 52 weeks or study discontinuation (Study Endpoint) | The mean change from baseline in Short-Form McGill Pain Questionnaire Scores at study endpoint. Visual Analogue Scale Score ranges from 0-100 mm. Higher scores indicate more severe pain. |
| Secondary | Change From Baseline in Short-Form McGill Pain Questionnaire: Present Pain Intensity Scores | From baseline to 52 weeks or study discontinuation (Study Endpoint) | The mean change from baseline in Short-Form McGill Pain Questionnaire Scores at study endpoint. Present pain intensity score ranges from 0-5. Higher scores indicate more severe pain. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Summary of Adverse Events | 53 weeks | Safety analysis set: all participants who had received at least one dose of the study drug. | participants | NUMBER |
| SECONDARY | Change From Baseline in Short-Form McGill Pain Questionnaire: Sensory Scores | From baseline to 52 weeks or study discontinuation (Study Endpoint) | Full analysis set. No imputations for missing data. | score on scale | MEAN |
| SECONDARY | Change From Baseline in Short-Form McGill Pain Questionnaire: Affective Scores | From baseline to 52 weeks or study discontinuation (Study Endpoint) | Full analysis set. No imputations for missing data. | score on scale | MEAN |
| SECONDARY | Change From Baseline in Short-Form McGill Pain Questionnaire: Total Scores | From baseline to 52 weeks or study discontinuation (Study Endpoint) | Full analysis set. No imputations for missing data. | score on scale | MEAN |
| SECONDARY | Change From Baseline in Short-Form McGill Pain Questionnaire: Visual Analogue Scale Scores | From baseline to 52 weeks or study discontinuation (Study Endpoint) | Full analysis set. No imputations for missing data. | mm | MEAN |
| SECONDARY | Change From Baseline in Short-Form McGill Pain Questionnaire: Present Pain Intensity Scores | From baseline to 52 weeks or study discontinuation (Study Endpoint) | Full analysis set. No imputations for missing data. | score on scale | MEAN |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Summary of Adverse Events | Pregabalin | Participants with adverse events | 114 | participants | |
| Summary of Adverse Events | Pregabalin | Participants with serious adverse events | 21 | participants | |
| Summary of Adverse Events | Pregabalin | Participants with severe adverse events | 7 | participants | |
| Summary of Adverse Events | Pregabalin | Participants discontinued due to adverse events | 17 | participants | |
| Summary of Adverse Events | Pregabalin | Dose reduced or temporary discontinuation | 43 | participants | |
| Change From Baseline in Short-Form McGill Pain Questionnaire: Sensory Scores | Pregabalin | -3.5 | Standard Deviation 5.1 | score on scale | |
| Change From Baseline in Short-Form McGill Pain Questionnaire: Affective Scores | Pregabalin | -1.2 | Standard Deviation 2.4 | score on scale | |
| Change From Baseline in Short-Form McGill Pain Questionnaire: Total Scores | Pregabalin | -4.7 | Standard Deviation 6.8 | score on scale | |
| Change From Baseline in Short-Form McGill Pain Questionnaire: Visual Analogue Scale Scores | Pregabalin | -25.4 | Standard Deviation 26.4 | mm | |
| Change From Baseline in Short-Form McGill Pain Questionnaire: Present Pain Intensity Scores | Pregabalin | -0.7 | Standard Deviation 1.1 | score on scale |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Pregabalin | 123 | |
| Overall Study | COMPLETED | Pregabalin | 97 | |
| Overall Study | NOT COMPLETED | Pregabalin | 26 |
Source ClinicalTrials.gov
Adverse events37
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Diabetic retinopathy | Eye disorders | Pregabalin | 9 | 123 | |
| other | Visual acuity reduced | Eye disorders | Pregabalin | 7 | 123 | |
| other | Constipation | Gastrointestinal disorders | Pregabalin | 11 | 123 | |
| other | Diarrhoea | Gastrointestinal disorders | Pregabalin | 8 | 123 | |
| other | Face oedema | General disorders | Pregabalin | 10 | 123 | |
| other | Oedema | General disorders | Pregabalin | 9 | 123 | |
| other | Oedema peripheral | General disorders | Pregabalin | 21 | 123 | |
| other | Nasopharyngitis | Infections and infestations | Pregabalin | 39 | 123 | |
| other | Contusion | Injury, poisoning and procedural complications | Pregabalin | 8 | 123 | |
| other | Fall | Injury, poisoning and procedural complications | Pregabalin | 14 | 123 |
1 to 10 of 37Source ClinicalTrials.gov
See all 37 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Pregabalin | ||
| Total, other adverse events | Pregabalin | 101 | 123 |
| Total, serious adverse events | Pregabalin | 21 | 123 |
Source ClinicalTrials.gov
Papers2
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.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license 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/NCT00553280
GET https://conductscience.org/api/trials/v1/NCT00553280/events?page=2