Trial · NCT00394901
A 13-Week, Randomized, Double-Blind, Multicenter, Placebo-Controlled Study Of Pregabalin For Postherpetic Neuralgia
NCT00394901, Phase 3, Completed, Pfizer's Upjohn has merged with Mylan to form Viatris Inc.; results first posted 2009-02-27
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A 13-Week, Randomized, Double-Blind, Multicenter, Placebo-Controlled Study Of Pregabalin For Postherpetic Neuralgia. Trials, record NCT00394901. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00394901
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A 13-Week, Randomized, Double-Blind, Multicenter, Placebo-Controlled Study Of Pregabalin For Postherpetic Neuralgia
- NCT number
- NCT00394901
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 372 participants, actual
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Conditions
- Neuralgia, Postherpetic
- Interventions
- Placebo, Pregabalin, Pregabalin, Pregabalin
- First posted
- 2006-11-02
- Last updated
- 2021-02-09
- Results first posted
- 2009-02-27
Source ClinicalTrials.gov
Registered outcomes55
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Pain Scores at Endpoint | Week13/discontinuation | Endpoint mean pain score is defined as the mean of the last 7 daily pain diary rating while taking the study medication, up to and including day after last dose. Scores range from 0-10 (11 points ordinal) with higher scores indicating increased pain. |
| Primary | Mean Pain Score at Endpoint by Groups of Subjects With Expected Similar Plasma Concentrations | Week13/discontinuation | Endpoint mean pain score is defined as the mean of the last 7 daily pain diary rating while taking the study medication, up to and including day after last dose. Scores range from 0-10 (11 points ordinal) with higher scores indicating increased pain. |
| Primary | Number of Responders | Week13/discontinuation | A responder is defined as a subject with a 50% reduction in weekly mean pain score from baseline to endpoint. |
| Primary | Mean Pain Scores at Week 1 | Week 1 | Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain. |
| Primary | Mean Pain Scores at Week 2 | Week 2 | Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain. |
| Primary | Mean Pain Scores at Week 3 | Week 3 | Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain. |
| Primary | Mean Pain Scores at Week 4 | Week4 | Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain. |
| Primary | Mean Pain Scores at Week 5 | Week 5 | Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain. |
| Primary | Mean Pain Scores at Week 6 | Week 6 | Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain. |
| Primary | Mean Pain Scores at Week 7 | Week 7 | Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain. |
1 to 10 of 55Source ClinicalTrials.gov
See all 55 registered outcomesOutcomes55
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Pain Scores at Endpoint | Week13/discontinuation | Full analysis set. Last observation carried forward. | score on scale | LEAST_SQUARES_MEAN |
| PRIMARY | Mean Pain Score at Endpoint by Groups of Subjects With Expected Similar Plasma Concentrations | Week13/discontinuation | Full analysis set. Last observation carried forward. | score on scale | LEAST_SQUARES_MEAN |
| PRIMARY | Number of Responders | Week13/discontinuation | Full analysis set. Last observation carried forward. | participants | NUMBER |
| PRIMARY | Mean Pain Scores at Week 1 | Week 1 | Full analysis set. Observed case. | score on scale | LEAST_SQUARES_MEAN |
| PRIMARY | Mean Pain Scores at Week 2 | Week 2 | Full analysis set. Observed case. | score on scale | LEAST_SQUARES_MEAN |
| PRIMARY | Mean Pain Scores at Week 3 | Week 3 | Full analysis set. Observed case. | score on scale | LEAST_SQUARES_MEAN |
| SECONDARY | Endpoint Sensory Scores of the Short-Form McGill Pain Questionnaire | Week13/discontinuation | Full analysis set. Last observation carried forward. | score on scale | LEAST_SQUARES_MEAN |
| SECONDARY | Endpoint Affective Scores of the Short-Form McGill Pain Questionnaire | Week13/discontinuation | Full analysis set. Last observation carried forward. | score on scale | LEAST_SQUARES_MEAN |
| SECONDARY | Endpoint Total Scores of the Short-Form McGill Pain Questionnaire | Week13/discontinuation | Full analysis set. Last observation carried forward | score on scale | LEAST_SQUARES_MEAN |
| SECONDARY | Endpoint Visual Analogue Scale Scores of the Short-Form McGill Pain Questionnaire | Week13/discontinuation | Full analysis set. Last observation carried forward. | mm | LEAST_SQUARES_MEAN |
1 to 10 of 55Source ClinicalTrials.gov
See all 55 outcomesResults by group219
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Pain Scores at Endpoint | Placebo | 5.12 | Standard Error 0.19 | score on scale | |
| Mean Pain Scores at Endpoint | Pregabalin 150 mg/Day | 4.81 | Standard Error 0.20 | score on scale | |
| Mean Pain Scores at Endpoint | Pregabalin 300 mg/Day | 4.26 | Standard Error 0.20 | score on scale | |
| Mean Pain Scores at Endpoint | Pregabalin 600 mg/Day | 4.49 | Standard Error 0.19 | score on scale | |
| Mean Pain Score at Endpoint by Groups of Subjects With Expected Similar Plasma Concentrations | Placebo | 4.99 | Standard Error 0.18 | score on scale | |
| Mean Pain Score at Endpoint by Groups of Subjects With Expected Similar Plasma Concentrations | Expected Pregabalin Exposure of 300 mg/Day | 4.35 | Standard Error 0.19 | score on scale | |
| Mean Pain Score at Endpoint by Groups of Subjects With Expected Similar Plasma Concentrations | Expected Pregabalin Exposure of 600 mg/Day | 4.34 | Standard Error 0.16 | score on scale | |
| Number of Responders | Placebo | 15 | participants | ||
| Number of Responders | Pregabalin 150 mg/Day | 21 | participants | ||
| Number of Responders | Pregabalin 300 mg/Day | 32 | participants |
1 to 10 of 219Source ClinicalTrials.gov
See all 219 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Baseline Phase | STARTED | Placebo | 98 | |
| Baseline Phase | STARTED | Pregabalin 150 mg/Day | 87 | |
| Baseline Phase | STARTED | Pregabalin 300 mg/Day | 90 | |
| Baseline Phase | STARTED | Pregabalin 600 mg/Day | 97 | |
| Baseline Phase | COMPLETED | Placebo | 98 | |
| Baseline Phase | COMPLETED | Pregabalin 150 mg/Day | 87 | |
| Baseline Phase | COMPLETED | Pregabalin 300 mg/Day | 89 | |
| Baseline Phase | COMPLETED | Pregabalin 600 mg/Day | 97 | |
| Baseline Phase | NOT COMPLETED | Placebo | 0 | |
| Baseline Phase | NOT COMPLETED | Pregabalin 150 mg/Day | 0 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events104
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 | Diplopia | Eye disorders | Placebo | 0 | 98 | |
| other | Diplopia | Eye disorders | Pregabalin 150 mg/Day | 0 | 87 | |
| other | Diplopia | Eye disorders | Pregabalin 300 mg/Day | 2 | 89 | |
| other | Diplopia | Eye disorders | Pregabalin 600 mg/Day | 6 | 97 | |
| other | Constipation | Gastrointestinal disorders | Placebo | 6 | 98 | |
| other | Constipation | Gastrointestinal disorders | Pregabalin 150 mg/Day | 12 | 87 | |
| other | Constipation | Gastrointestinal disorders | Pregabalin 300 mg/Day | 11 | 89 | |
| other | Constipation | Gastrointestinal disorders | Pregabalin 600 mg/Day | 14 | 97 | |
| other | Nausea | Gastrointestinal disorders | Placebo | 5 | 98 | |
| other | Nausea | Gastrointestinal disorders | Pregabalin 150 mg/Day | 2 | 87 |
1 to 10 of 104Source ClinicalTrials.gov
See all 104 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | Pregabalin 150 mg/Day | ||
| Total, all-cause mortality | Pregabalin 300 mg/Day | ||
| Total, all-cause mortality | Pregabalin 600 mg/Day | ||
| Total, other adverse events | Placebo | 35 | 98 |
| Total, other adverse events | Pregabalin 150 mg/Day | 44 | 87 |
| Total, other adverse events | Pregabalin 300 mg/Day | 61 | 89 |
| Total, other adverse events | Pregabalin 600 mg/Day | 77 | 97 |
| Total, serious adverse events | Placebo | 6 | 98 |
| Total, serious adverse events | Pregabalin 150 mg/Day | 2 | 87 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
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/NCT00394901
GET https://conductscience.org/api/trials/v1/NCT00394901/registered?page=2