Trial · NCT00264875
Open Label Safety And Efficacy Study Of Pregabalin In Subjects With Nerve Pain Asociated With Human Immunodeficiency Virus (HIV) Neuropathy
NCT00264875, Phase 3, Completed, Pfizer's Upjohn has merged with Mylan to form Viatris Inc.; results first posted 2009-03-23
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Open Label Safety And Efficacy Study Of Pregabalin In Subjects With Nerve Pain Asociated With Human Immunodeficiency Virus (HIV) Neuropathy. Trials, record NCT00264875. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00264875
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Open Label Safety And Efficacy Study Of Pregabalin In Subjects With Nerve Pain Asociated With Human Immunodeficiency Virus (HIV) Neuropathy
- NCT number
- NCT00264875
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 220 participants, actual
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Conditions
- Peripheral Neuropathy, HIV Infections
- Interventions
- pregabalin
- First posted
- 2005-12-13
- Last updated
- 2021-01-22
- Results first posted
- 2009-03-23
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Visual Analogue Scale (VAS) Pain Scores | Baseline, Week 4, Week 8, Week 12, and Endpoint | Pain scores were assessed on a 100 mm Visual Analogue Scale (VAS); scores range from 0= no pain to 100= worse pain. Subjects assessed their pain during the last week. Endpoint = last non-missing observation carried forward after Baseline visit. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Visual Analogue Scale (VAS) Pain Scores | Baseline, Week 4, Week 8, Week 12, and Endpoint | The full analysis set was defined as all subjects who met all eligibility criteria and took at least one dose of study medication. | score on scale | MEAN |
Source ClinicalTrials.gov
Results by group5
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Visual Analogue Scale (VAS) Pain Scores | Pregabalin | Baseline (n=203) | 38.61 | Standard Deviation 27.10 | score on scale |
| Mean Visual Analogue Scale (VAS) Pain Scores | Pregabalin | Week 4 (n=204) | 30.75 | Standard Deviation 25.19 | score on scale |
| Mean Visual Analogue Scale (VAS) Pain Scores | Pregabalin | Week 8 (n=200) | 30.16 | Standard Deviation 25.78 | score on scale |
| Mean Visual Analogue Scale (VAS) Pain Scores | Pregabalin | Week 12 (n=207) | 28.95 | Standard Deviation 26.05 | score on scale |
| Mean Visual Analogue Scale (VAS) Pain Scores | Pregabalin | Endpoint (n=217) | 29.39 | Standard Deviation 26.32 | 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 | 220 | |
| Overall Study | COMPLETED | Pregabalin | 190 | |
| Overall Study | NOT COMPLETED | Pregabalin | 30 |
Source ClinicalTrials.gov
Adverse events27
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 | Dizziness | Nervous system disorders | Pregabalin | 22 | 220 | |
| other | Somnolence | Nervous system disorders | Pregabalin | 21 | 220 | |
| other | Peripheral edema | General disorders | Pregabalin | 13 | 220 | |
| other | Diarrhea | Gastrointestinal disorders | Pregabalin | 12 | 220 | |
| other | Fatigue | General disorders | Pregabalin | 11 | 220 | |
| other | Euphoric mood | Psychiatric disorders | Pregabalin | 8 | 220 | |
| other | Headache | Nervous system disorders | Pregabalin | 8 | 220 | |
| other | Cough | Respiratory, thoracic and mediastinal disorders | Pregabalin | 7 | 220 | |
| other | Dry mouth | Gastrointestinal disorders | Pregabalin | 7 | 220 | |
| other | Pain in extremity | Musculoskeletal and connective tissue disorders | Pregabalin | 7 | 220 |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 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 | 82 | |
| Total, serious adverse events | Pregabalin | 10 |
Source ClinicalTrials.gov
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.
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/NCT00264875
GET https://conductscience.org/api/trials/v1/NCT00264875/events?page=2