Trial · NCT00407511
Pregabalin Treatment Of Peripheral Neuropathic Pain Associated With Diabetic Peripheral NeP (DPN), Postherpetic Neuralgia (PHN), HIV-related NeP (HIV), and Chemotherapy Induced NeP
NCT00407511, Phase 4, Completed, Pfizer's Upjohn has merged with Mylan to form Viatris Inc.; results first posted 2009-08-19
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Pregabalin Treatment Of Peripheral Neuropathic Pain Associated With Diabetic Peripheral NeP (DPN), Postherpetic Neuralgia (PHN), HIV-related NeP (HIV), and Chemotherapy Induced NeP. Trials, record NCT00407511. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00407511
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pregabalin Treatment Of Peripheral Neuropathic Pain Associated With Diabetic Peripheral NeP (DPN), Postherpetic Neuralgia (PHN), HIV-related NeP (HIV), and Chemotherapy Induced NeP
- NCT number
- NCT00407511
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 121 participants, actual
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Conditions
- Diabetic Peripheral Neuropathic Pain (DPN), Postherpetic Neuralgia (PHN), HIV-related Neuropathic Pain (HIV), Chemotherapy Induced Neuropathic Pain
- Interventions
- Pregabalin
- First posted
- 2006-12-05
- Last updated
- 2021-02-09
- Results first posted
- 2009-08-19
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline to End of Treatment (EOT) in Weekly Mean Pain Score on the Daily Pain Rating Scale (DPRS) | Baseline, End of Treatment | 11 point Likert scale: range 0 to 10 (no pain to worst possible pain) over past 24 hours. Baseline score = mean score of preceding 7 days (including Visit 2). Final end of treatment (EOT) pain score = mean pain score from last 7 post-Baseline days preceding Visit 8 (Week 12) or last 7 days on study drug for those who did not complete the study. Change = mean at EOT minus mean at Baseline. |
| Secondary | Change From Baseline in Mean Pain Score on the Daily Pain Rating Scale (DPRS) | Week 4, Week 8, Week 12 | 11 point Likert scale; range: 0 to 10 (no pain to worst possible pain) over past 24 hours. Baseline score = mean score of preceding 7 days (including Visit 2). Weekly pain score = mean pain score from last 7 post-Baseline days preceding observation visit or last 7 days on study drug for early termination. Change = mean at observation minus mean at Baseline. |
| Secondary | Change From Baseline (BL) in Modified Brief Pain Inventory-Short Form (m-BPI-sf): Pain Severity Index Scores | Baseline, Week 8, Week 12, EOT/LOCF | Self-administered questionnaire: change from Baseline in mean pain severity index over past 24 hours; 11-point numeric rating scale ranging from 0 (no pain) to 10 (worst pain possible). Pain severity index is the mean of item scores 2, 3, and 4 (pain right now, worst pain, and average pain level). Change = mean score at observation minus mean score at Baseline. |
| Secondary | Change From Baseline in Modified Brief Pain Inventory-Short Form (m-BPI-sf): Pain Interference Index Scores | Baseline, Week 8, Week 12, End of Treatment/Last Observation Carried Forward (EOT/LOCF) | Self-administered questionnaire: change from Baseline in mean pain interference with functional activities (general activity, mood, walking ability, relations with other people, sleep, normal work, and enjoyment of life) in past 24 hours. 11-point scale from 0 (does not interfere) to 10 (completely interferes). Change = observation mean minus Baseline mean. |
| Secondary | Pain Treatment Satisfaction Scale (PTSS): Impact of Current Pain Medication | Baseline, Week 8, Week 12, EOT/LOCF | Impact of current pain medication response scale: 0 (worst possible response) to 100 (best possible response). Score=\[(5-mean of non-missing items)\*100\]/4. |
| Secondary | Pain Treatment Satisfaction Scale (PTSS): Satisfaction With Current Pain Medication | Baseline, Week 8, Week 12, EOT/LOCF | Satisfaction with current pain medication response scale: 0 (worst possible response) to 100 (best possible response). Score=\[(5-mean of non-missing items)\*100\]/4. |
| Secondary | Change From Baseline in Visual Analogue Scale for Pain (VAS-pain) | Baseline, Week 1, Week 2, Week 3, Week 4, Week 8, Week 12, EOT/LOCF | 100 mm line (Visual Analog Scale) marked by subject; Intensity of pain range (over past week): 0 = no pain to 100 = worst possible pain. Change = observation mean minus Baseline mean. |
| Secondary | Change From Baseline in Global Anxiety Visual Analogue Scale (GA-VAS) | Baseline, Week 8, Week 12, EOT/LOCF | 100-mm line (Visual Analog Scale) marked by the subject to measure their degree of anxiety over past 24 hours. Range: 0 = not at all anxious to 100 = extremely anxious. Change = mean score at observation minus mean score at Baseline. |
| Secondary | Change From Baseline in Mean Daily Sleep Interference Score (DSIS) | Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11, Week 12, EOT/LOCF | Daily sleep interference measured on an 11-point Likert scale. Range: 0 (pain did not interfere with sleep) to 10 (pain completely interfered with sleep). Change = mean at observation minus mean at Baseline. Evaluations recorded in patient's daily sleep diaries. |
| Secondary | Patient Global Impression of Change (PGIC) | End of Treatment/ Last Observation Carried Forward (Week 12 or last post-baseline assessment) | 7-point participant rating scale for change observed in their overall status since beginning of study medication. Range: 1 (very much improved) to 7 (very much worse) |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline to End of Treatment (EOT) in Weekly Mean Pain Score on the Daily Pain Rating Scale (DPRS) | Baseline, End of Treatment | Full Analysis Set (FAS): patients who took at least one dose of study medication, had a baseline value, and had at least one post-baseline measurement; Last Observation Carried Forward (LOCF). | scores on scale | MEAN |
| SECONDARY | Change From Baseline in Mean Pain Score on the Daily Pain Rating Scale (DPRS) | Week 4, Week 8, Week 12 | Full Analysis Set (FAS). | scores on scale | MEAN |
| SECONDARY | Change From Baseline (BL) in Modified Brief Pain Inventory-Short Form (m-BPI-sf): Pain Severity Index Scores | Baseline, Week 8, Week 12, EOT/LOCF | Full Analysis Set (FAS); End of Treatment/Last Observation Carried Forward (EOT/LOCF): last post-baseline assessment. | scores on scale | MEAN |
| SECONDARY | Change From Baseline in Modified Brief Pain Inventory-Short Form (m-BPI-sf): Pain Interference Index Scores | Baseline, Week 8, Week 12, End of Treatment/Last Observation Carried Forward (EOT/LOCF) | Full Analysis Set (FAS); End of Treatment/Last Observation Carried Forward (EOT/LOCF): last post-baseline assessment. | scores on scale | MEAN |
| SECONDARY | Pain Treatment Satisfaction Scale (PTSS): Impact of Current Pain Medication | Baseline, Week 8, Week 12, EOT/LOCF | Full Analysis Set (FAS); End of Treatment/Last Observation Carried Forward (EOT/LOCF): last post-baseline assessment. Subjects were only included in the Week 8 analysis if their visit fell between Days 49 and 63, and were only included in the Week 12 analysis if their visit was after Day 78. | scores on scale | MEAN |
| SECONDARY | Pain Treatment Satisfaction Scale (PTSS): Satisfaction With Current Pain Medication | Baseline, Week 8, Week 12, EOT/LOCF | Full Analysis Set (FAS); End of Treatment/Last Observation Carried Forward (EOT/LOCF): last post-baseline assessment. Subjects were only included in the Week 8 analysis if their visit fell between Days 49 and 63, and were only included in the Week 12 analysis if their visit was after Day 78. | scores on scale | MEAN |
| SECONDARY | Change From Baseline in Visual Analogue Scale for Pain (VAS-pain) | Baseline, Week 1, Week 2, Week 3, Week 4, Week 8, Week 12, EOT/LOCF | Full Analysis Set (FAS); End of Treatment/Last Observation Carried Forward (EOT/LOCF): last post-baseline assessment. | scores on scale | MEAN |
| SECONDARY | Change From Baseline in Global Anxiety Visual Analogue Scale (GA-VAS) | Baseline, Week 8, Week 12, EOT/LOCF | Full Analysis Set (FAS); End of Treatment/Last Observation Carried Forward (EOT/LOCF): last post-baseline assessment. | scores on scale | MEAN |
| SECONDARY | Change From Baseline in Mean Daily Sleep Interference Score (DSIS) | Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11, Week 12, EOT/LOCF | Full Analysis Set (FAS); End of Treatment/Last Observation Carried Forward (EOT/LOCF): last post-baseline assessment. | scores on scale | MEAN |
| SECONDARY | Patient Global Impression of Change (PGIC) | End of Treatment/ Last Observation Carried Forward (Week 12 or last post-baseline assessment) | Full Analysis Set (FAS) | participants | NUMBER |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group55
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline to End of Treatment (EOT) in Weekly Mean Pain Score on the Daily Pain Rating Scale (DPRS) | Pregabalin | -3.8 | Standard Deviation 2.5 | scores on scale | |
| Change From Baseline in Mean Pain Score on the Daily Pain Rating Scale (DPRS) | Pregabalin | Week 4 (n=110) | -3.2 | Standard Deviation 1.9 | scores on scale |
| Change From Baseline in Mean Pain Score on the Daily Pain Rating Scale (DPRS) | Pregabalin | Week 8 (n=100) | -3.9 | Standard Deviation 2.3 | scores on scale |
| Change From Baseline in Mean Pain Score on the Daily Pain Rating Scale (DPRS) | Pregabalin | Week 12 (n=96) | -4.2 | Standard Deviation 2.4 | scores on scale |
| Change From Baseline (BL) in Modified Brief Pain Inventory-Short Form (m-BPI-sf): Pain Severity Index Scores | Pregabalin | Week 8 (n=102) | -4.2 | Standard Deviation 2.6 | scores on scale |
| Change From Baseline (BL) in Modified Brief Pain Inventory-Short Form (m-BPI-sf): Pain Severity Index Scores | Pregabalin | Week 12 (n=98) | -4.7 | Standard Deviation 2.6 | scores on scale |
| Change From Baseline (BL) in Modified Brief Pain Inventory-Short Form (m-BPI-sf): Pain Severity Index Scores | Pregabalin | EOT/LOCF (n=102) | -4.6 | Standard Deviation 2.6 | scores on scale |
| Change From Baseline in Modified Brief Pain Inventory-Short Form (m-BPI-sf): Pain Interference Index Scores | Pregabalin | Week 8 (n=102) | -3.8 | Standard Deviation 2.7 | scores on scale |
| Change From Baseline in Modified Brief Pain Inventory-Short Form (m-BPI-sf): Pain Interference Index Scores | Pregabalin | Week 12 (n=98) | -4.2 | Standard Deviation 2.6 | scores on scale |
| Change From Baseline in Modified Brief Pain Inventory-Short Form (m-BPI-sf): Pain Interference Index Scores | Pregabalin | EOT/LOCF (n=102) | -4.0 | Standard Deviation 2.6 | scores on scale |
1 to 10 of 55Source ClinicalTrials.gov
See all 55 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Pregabalin | 121 | |
| Overall Study | COMPLETED | Pregabalin | 99 | |
| Overall Study | NOT COMPLETED | Pregabalin | 22 |
Source ClinicalTrials.gov
Adverse events16
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 | Dry mouth | Gastrointestinal disorders | Pregabalin | 8 | 121 | |
| other | Nausea | Gastrointestinal disorders | Pregabalin | 6 | 121 | |
| other | Oedema | General disorders | Pregabalin | 7 | 121 | |
| other | Oedema peripheral | General disorders | Pregabalin | 14 | 121 | |
| other | Weight increased | Investigations | Pregabalin | 15 | 121 | |
| other | Increased appetite | Metabolism and nutrition disorders | Pregabalin | 7 | 121 | |
| other | Dizziness | Nervous system disorders | Pregabalin | 25 | 121 | |
| other | Headache | Nervous system disorders | Pregabalin | 8 | 121 | |
| other | Somnolence | Nervous system disorders | Pregabalin | 38 | 121 | |
| serious | Cardiac failure | Cardiac disorders | Pregabalin | 1 | 121 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 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 | 69 | |
| Total, serious adverse events | Pregabalin | 4 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 20487048 | DERIVED |
Source PubMed
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
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The record and each of its lists are JSON, twenty rows a page. No key.
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