Trial · NCT02394951
Pregabalin in CIPN
NCT02394951, Not applicable, Completed, Washington University School of Medicine; results first posted 2019-05-14
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Pregabalin in CIPN. Trials, record NCT02394951. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02394951
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pregabalin in CIPN
- NCT number
- NCT02394951
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 26 participants, actual
- Lead sponsor
- Washington University School of Medicine
- Conditions
- Neuropathy, Pain
- Interventions
- Pregabalin, Placebo
- First posted
- 2015-03-20
- Last updated
- 2019-05-14
- Results first posted
- 2019-05-14
- Limitations and caveats
- Early termination due to slow recruitment
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Spontaneous Pain Intensity as a Function of Baseline MPT | Baseline to week 4 | Correlation between Mechanical Pain Threshold (MPT in mN) at baseline and reduction in spontaneous pain intensity (% reduction on 0-10 NRS) at the end of 4-week treatment. The slopes (Pearson coefficients) of the correlation obtained from pregabalin vs. placebo will be compared. |
| Secondary | Absolute Change in Pain Intensity, Measured on 0-10 Numerical Rating Scale (NRS) | Baseline to week 4 | Absolute change in pain intensity on 0-10 numerical rating scale (NRS) from baseline to 4 weeks with pregabalin vs. placebo NRS: 0= no pain, 10= worst pain |
| Secondary | Change in NPSI Outcomes | Baseline to week 4 | Change from baseline to week 4 in total NPSI (Neuropathic Pain Symptom Inventory) score The total NPSI score is comprised by adding 5 sub-scores (Burning pain, Pressing pain, Paroxysmal pain, Evoked pain, and Paresthesia/Dysesthesia) and is expressed on a 0-100 scale; 0-minimum (least), and 100 maximum (worst) score |
| Secondary | Change in BPI Outcomes (SEVERITY) | Baseline to week 4 | Change from baseline to week 4 in BPI (Brief Pain Inventory) pain severity severity score BPI severity score is expressed on 0-10 scale, with 0 being the minimum (least), and 10 being the maximum (worst) pain severity |
| Secondary | Change in Sleep Problem Index (SPI) Outcomes | Baseline to week 4 | Change from baseline to week 4 in SPI (Sleep Problem Index) score, on 0-100 scale, where 0= best (least) score, and 100= maximum (worst) score |
| Secondary | Change in BPI Outcomes (INTERFERENCE) | baseline to week 4 | Change from baseline to week 4 in BPI (Brief Pain Inventory) pain interference score BPI interference score is expressed on 0-10 scale, with 0 being the minimum (least), and 10 being the maximum (worst) pain interference |
| Secondary | Number of Patients With Significant Pain Reduction | Baseline to week 4 | Number of patients who experienced 50% or more reduction in average daily pain (on 0-10 NRS, Numerical Rating Scale, where 0=least pain, 10=worst pain) |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Spontaneous Pain Intensity as a Function of Baseline MPT | Baseline to week 4 | Pearson correlation coefficient | NUMBER | |
| SECONDARY | Absolute Change in Pain Intensity, Measured on 0-10 Numerical Rating Scale (NRS) | Baseline to week 4 | units on a scale (0-10 NRS) | MEAN | |
| SECONDARY | Change in NPSI Outcomes | Baseline to week 4 | units on a scale (0-100 NPSI score) | MEAN | |
| SECONDARY | Change in BPI Outcomes (SEVERITY) | Baseline to week 4 | units on a scale (0-10 BPI severity) | MEAN | |
| SECONDARY | Change in Sleep Problem Index (SPI) Outcomes | Baseline to week 4 | units on a scale (0-100 SPI) | MEAN | |
| SECONDARY | Change in BPI Outcomes (INTERFERENCE) | baseline to week 4 | units on a scale (0-10 BPI interference) | MEAN | |
| SECONDARY | Number of Patients With Significant Pain Reduction | Baseline to week 4 | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Spontaneous Pain Intensity as a Function of Baseline MPT | Pregabalin | -0.0179 | 95% Confidence Interval -0.0459 to 0.0101 | Pearson correlation coefficient | |
| Change in Spontaneous Pain Intensity as a Function of Baseline MPT | Placebo | -0.0172 | 95% Confidence Interval -0.0514 to 0.0170 | Pearson correlation coefficient | |
| Absolute Change in Pain Intensity, Measured on 0-10 Numerical Rating Scale (NRS) | Pregabalin | -1.0 | Standard Deviation 1.13 | units on a scale (0-10 NRS) | |
| Absolute Change in Pain Intensity, Measured on 0-10 Numerical Rating Scale (NRS) | Placebo | 0.3 | Standard Deviation 1.10 | units on a scale (0-10 NRS) | |
| Change in NPSI Outcomes | Pregabalin | -9.8 | Standard Deviation 12.49 | units on a scale (0-100 NPSI score) | |
| Change in NPSI Outcomes | Placebo | 1.8 | Standard Deviation 20.93 | units on a scale (0-100 NPSI score) | |
| Change in BPI Outcomes (SEVERITY) | Pregabalin | -0.8 | Standard Deviation 1.52 | units on a scale (0-10 BPI severity) | |
| Change in BPI Outcomes (SEVERITY) | Placebo | -0.1 | Standard Deviation 1.14 | units on a scale (0-10 BPI severity) | |
| Change in Sleep Problem Index (SPI) Outcomes | Pregabalin | -5.1 | Standard Deviation 9.45 | units on a scale (0-100 SPI) | |
| Change in Sleep Problem Index (SPI) Outcomes | Placebo | -4.1 | Standard Deviation 11.64 | units on a scale (0-100 SPI) |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Period I | STARTED | Pregabalin First Then Placebo | 12 | |
| Period I | STARTED | Placebo First Then Pregabalin | 14 | |
| Period I | COMPLETED | Pregabalin First Then Placebo | 11 | |
| Period I | COMPLETED | Placebo First Then Pregabalin | 13 | |
| Period I | NOT COMPLETED | Pregabalin First Then Placebo | 1 | |
| Period I | NOT COMPLETED | Placebo First Then Pregabalin | 1 | |
| Period II | STARTED | Pregabalin First Then Placebo | 11 | |
| Period II | STARTED | Placebo First Then Pregabalin | 13 | |
| Period II | COMPLETED | Pregabalin First Then Placebo | 11 | |
| Period II | COMPLETED | Placebo First Then Pregabalin | 9 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events24
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 | 17 | 25 | |
| other | Dizziness | Nervous system disorders | Placebo | 4 | 25 | |
| other | Somnolence | Nervous system disorders | Pregabalin | 22 | 25 | |
| other | Somnolence | Nervous system disorders | Placebo | 11 | 25 | |
| other | Dry Mouth | Gastrointestinal disorders | Pregabalin | 14 | 25 | |
| other | Dry Mouth | Gastrointestinal disorders | Placebo | 10 | 25 | |
| other | Edema | General disorders | Pregabalin | 8 | 25 | |
| other | Edema | General disorders | Placebo | 8 | 25 | |
| other | Weight Gain | Investigations | Pregabalin | 4 | 25 | |
| other | Weight Gain | Investigations | Placebo | 1 | 25 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Pregabalin | 0 | 25 |
| Total, all-cause mortality | Placebo | 0 | 25 |
| Total, other adverse events | Pregabalin | 23 | 25 |
| Total, other adverse events | Placebo | 21 | 25 |
| Total, serious adverse events | Pregabalin | 1 | 25 |
| Total, serious adverse events | Placebo | 0 | 25 |
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Pregabalin vs Placebo: Number of Patients With Significant Pain Reduction | Trial comparisons |
| Pregabalin vs Placebo: deaths from any cause | Trial comparisons |
| Pregabalin vs Placebo: serious adverse events | Trial comparisons |
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/NCT02394951
GET https://conductscience.org/api/trials/v1/NCT02394951/events?page=2