Trial · NCT01117766
Study To Assess The Reproducibility And Sensitivity Of Quantitative Sensory Testing In Patients With Neuropathic Pain
NCT01117766, Not applicable, Completed, Pfizer; results first posted 2010-09-27
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study To Assess The Reproducibility And Sensitivity Of Quantitative Sensory Testing In Patients With Neuropathic Pain. Trials, record NCT01117766. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01117766
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study To Assess The Reproducibility And Sensitivity Of Quantitative Sensory Testing In Patients With Neuropathic Pain
- NCT number
- NCT01117766
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 31 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Neuropathic Pain
- Interventions
- Pregabalin, Placebo
- First posted
- 2010-05-05
- Last updated
- 2019-04-23
- Results first posted
- 2010-09-27
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Change From Baseline in Dynamic Allodynia Intensity at Visits 3 and 6 and Visits 4 and 7 | Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each period | Five strokes applied with a standardized brush (somedic) across the painful site, 6cm long and at a control site to allow the participants to appreciate any difference. A painful and clearly dysaesthetic (unpleasant) sensation was considered as representing brush allodynia (whereas a "strange" or "tickly" sensation provoked by the brush was not). After each brush stimuli participants were asked to give a pain rating using 11-point numerical rating scale (NRS) where 0=no pain and 10=worst pain imaginable. The average of 5 brush strokes was calculated to obtain the mean score. |
| Primary | Mean Change From Baseline in Dynamic Allodynia Area at Visits 3 and 6 and Visits 4 and 7 | Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each period | Dynamic area brush in cm\^2: calculated from 8 measured distances by calculating the area of an octagon. The angle between each pair of lines was 45 degrees at point c. The area of the octagon was found by totaling the areas of the 8 triangles. Octagon with 8 radial lengths from center to the outside. Area = Σ ( ½ length \* perpendicular height); Σ ( ½ ri \* sin(45) r(i+1) ) = Σ ( (ri \* r(i+1) )/2√2)). (where ri, i=1 to 8, were the eight radial lengths) |
| Primary | Mean Change From Baseline in Mechanical Pain Sensitivity (Von Frey) at Visits 3 and 6 and Visits 4 and 7 | Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each period | Sensitivity to mechanical pain stimuli was tested using calibrated Von Frey monofilaments. To obtain a stimulus-response-function, seven different Von Frey monofilaments (size 8 to 512 mN, force increased by a factor of two from filament to filament) applied three times each; each stimulus was participant-rated using 11-point NRS where 0=no pain and 10=worst pain imaginable. If a score of 8 or more was reported for a given intensity no stronger stimuli was applied. Von Frey stimulus was applied to the skin for 1 to 2 seconds. The average of 3 ratings was calculated for the mean score. |
| Primary | Mean Change From Baseline in Punctate Allodynia Area (Von Frey) at Visits 3 and 6 and Visits 4 and 7 | Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each period | Punctate allodynia area in cm\^2: calculated from 8 measured distances by calculating the area of an octagon. The angle between each pair of lines was 45 degrees at point c. The area of the octagon was found by totaling the areas of the 8 triangles. Octagon with 8 radial lengths from center to the outside. Area = Σ ( ½ length \* perpendicular height); Σ ( ½ ri \* sin(45) r(i+1) ) = Σ ( (ri \* r(i+1) )/2√2)). (where ri, i=1 to 8, were the eight radial lengths) |
| Primary | Mean Change From Baseline in Cold Pain Sensitivity at Visits 3 and 6 and Visits 4 and 7 | Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each period | Duration of thermal stimuli was 2 seconds and an intensity that is increased in steps of 5 degrees celsius for cold stimuli (between 5 and 20 degrees celsius). Thermal pain sensitivity was participant-rated using 11-point NRS where 0=no pain and 10=worst pain imaginable. The average of 2 ratings was calculated to get the mean score. |
| Primary | Mean Change From Baseline in Heat Pain Sensitivity at Visits 3 and 6 and Visits 4 and 7 | Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each period | Duration of thermal stimuli was 2 seconds and an intensity that is increased in steps of 4 degrees celsius for heat stimuli (between 40 and 50 degrees celsius). Thermal pain sensitivity was participant-rated using 11-point NRS where 0=no pain and 10=worst pain imaginable. The average of 2 ratings was calculated to get the mean score. |
| Secondary | Mean Change From Baseline in Weekly Pain Score From the Daily Diary at Visits 3 and 6 and Visits 4 and 7 | Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each period | Daily pain diary: participant-rated pain during the past 24 hours rated on an 11 point NRS scale where 0=no pain and 10=worst possible pain. For a given week, the pain response was the average of the 7 daily entries for that week, or average of the available data for that week if fewer than 7 entries were recorded (\>=1 daily pain score for any given week required). The endpoint for each week consisted of the change from baseline in average pain score (follow-up value minus baseline). |
| Secondary | Mean Change From Baseline in Patient's Global Impression of Change (PGIC) at Visits 3 and 6 and Visits 4 and 7 | Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each period | PGIC: participant-rated assessment measuring change in participant's overall status on a 7-point scale from 1=very much improved to 7=very much worse. |
| Secondary | Mean Change From Baseline in Test-Day Global Pain Intensity at Visits 3 and 6 and Visits 4 and 7 | Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each period | Global pain: participant-rated pain using the test-day global pain scale, consisting of an 11-point NRS where 0 = no pain and 10 = worst possible pain. Participants described intensity of pain in response to "How intense is your pain today?" |
| Secondary | Mean Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) Total Score at Visits 4 and 7 | Week 4 (Visits 4 and 7) of each period | NPSI: 10-item self-administered questionnaire assessing 5 dimensions of pain (burning superficial spontaneous pain, pressing deep spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dysesthesia). Each item consists of a question about the specific qualities of pain and an 11-point numerical scale range: 0 (absence of pain) to 10 (maximum intensity imaginable), and 2 temporal items related to spontaneous and paroxysmal pain. Maximum total score possible = 100. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Change From Baseline in Dynamic Allodynia Intensity at Visits 3 and 6 and Visits 4 and 7 | Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each period | Full analysis set (FAS)=participants with present pain intensity score \>=4 out of 10 for brush evoked allodynia at screening and randomization, \>=4 out of 7 non missing values in week prior to randomization, \>4 for weekly average daily pain score, and who did not withdraw/discontinue. n=number of participants contributing to the mean. | scores on a scale | MEAN |
| PRIMARY | Mean Change From Baseline in Dynamic Allodynia Area at Visits 3 and 6 and Visits 4 and 7 | Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each period | FAS. n=number of participants contributing to the mean. | cm2 | MEAN |
| PRIMARY | Mean Change From Baseline in Mechanical Pain Sensitivity (Von Frey) at Visits 3 and 6 and Visits 4 and 7 | Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each period | FAS. n=number of participants contributing to the mean. Missing values were imputed using a single imputation regression method. | scores on a scale | MEAN |
| PRIMARY | Mean Change From Baseline in Punctate Allodynia Area (Von Frey) at Visits 3 and 6 and Visits 4 and 7 | Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each period | FAS. n=number of participants contributing to the mean. | cm2 | MEAN |
| PRIMARY | Mean Change From Baseline in Cold Pain Sensitivity at Visits 3 and 6 and Visits 4 and 7 | Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each period | FAS. n=number of participants contributing to the mean. Missing values were imputed using a single imputation regression method. | scores on a scale | MEAN |
| PRIMARY | Mean Change From Baseline in Heat Pain Sensitivity at Visits 3 and 6 and Visits 4 and 7 | Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each period | FAS. n=number of participants contributing to the mean. Missing values were imputed using a single imputation regression method. | scores on a scale | MEAN |
| SECONDARY | Mean Change From Baseline in Weekly Pain Score From the Daily Diary at Visits 3 and 6 and Visits 4 and 7 | Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each period | FAS. n=number of participants contributing to the mean. Missing weeks within a period were imputed using last observation carried forward (LOCF). | scores on a scale | MEAN |
| SECONDARY | Mean Change From Baseline in Patient's Global Impression of Change (PGIC) at Visits 3 and 6 and Visits 4 and 7 | Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each period | FAS. n=number of participants contributing to the mean. | scores on a scale | MEAN |
| SECONDARY | Mean Change From Baseline in Test-Day Global Pain Intensity at Visits 3 and 6 and Visits 4 and 7 | Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each period | FAS. n=number of participants contributing to the mean. | scores on a scale | MEAN |
| SECONDARY | Mean Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) Total Score at Visits 4 and 7 | Week 4 (Visits 4 and 7) of each period | FAS. n=18, 18; number of participants contributing to the mean. | scores on a scale | MEAN |
Source ClinicalTrials.gov
Results by group86
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Change From Baseline in Dynamic Allodynia Intensity at Visits 3 and 6 and Visits 4 and 7 | Pregabalin | Week 3 (Visits 3 and 6) (n=15,16) | -1.09 | Standard Deviation 1.735 | scores on a scale |
| Mean Change From Baseline in Dynamic Allodynia Intensity at Visits 3 and 6 and Visits 4 and 7 | Placebo | Week 3 (Visits 3 and 6) (n=15,16) | -1.16 | Standard Deviation 1.730 | scores on a scale |
| Mean Change From Baseline in Dynamic Allodynia Intensity at Visits 3 and 6 and Visits 4 and 7 | Pregabalin | Week 4 (Visits 4 and 7) (n=18,21) | -1.31 | Standard Deviation 1.924 | scores on a scale |
| Mean Change From Baseline in Dynamic Allodynia Intensity at Visits 3 and 6 and Visits 4 and 7 | Placebo | Week 4 (Visits 4 and 7) (n=18,21) | -0.67 | Standard Deviation 1.984 | scores on a scale |
| Mean Change From Baseline in Dynamic Allodynia Area at Visits 3 and 6 and Visits 4 and 7 | Pregabalin | Week 3 (Visits 3 and 6) (n=16,17) | -53.441 | Standard Deviation 114.7084 | cm2 |
| Mean Change From Baseline in Dynamic Allodynia Area at Visits 3 and 6 and Visits 4 and 7 | Placebo | Week 3 (Visits 3 and 6) (n=16,17) | -49.180 | Standard Deviation 94.3329 | cm2 |
| Mean Change From Baseline in Dynamic Allodynia Area at Visits 3 and 6 and Visits 4 and 7 | Pregabalin | Week 4 (Visits 4 and 7) (n=17,20) | -49.808 | Standard Deviation 100.2094 | cm2 |
| Mean Change From Baseline in Dynamic Allodynia Area at Visits 3 and 6 and Visits 4 and 7 | Placebo | Week 4 (Visits 4 and 7) (n=17,20) | -18.921 | Standard Deviation 104.3942 | cm2 |
| Mean Change From Baseline in Mechanical Pain Sensitivity (Von Frey) at Visits 3 and 6 and Visits 4 and 7 | Pregabalin | Week 3 (Visits 3 and 6) (Size 8, n=15,16) | -0.133 | Standard Deviation 1.7494 | scores on a scale |
| Mean Change From Baseline in Mechanical Pain Sensitivity (Von Frey) at Visits 3 and 6 and Visits 4 and 7 | Placebo | Week 3 (Visits 3 and 6) (Size 8, n=15,16) | 0.417 | Standard Deviation 2.6063 | scores on a scale |
1 to 10 of 86Source ClinicalTrials.gov
See all 86 results by groupParticipant flow20
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| First Intervention | STARTED | Pregabalin Then Placebo | 14 | |
| First Intervention | STARTED | Placebo Then Pregabalin | 17 | |
| First Intervention | Received Treatment | Pregabalin Then Placebo | 14 | |
| First Intervention | Received Treatment | Placebo Then Pregabalin | 17 | |
| First Intervention | COMPLETED | Pregabalin Then Placebo | 13 | |
| First Intervention | COMPLETED | Placebo Then Pregabalin | 16 | |
| First Intervention | NOT COMPLETED | Pregabalin Then Placebo | 1 | |
| First Intervention | NOT COMPLETED | Placebo Then Pregabalin | 1 | |
| Washout Period | STARTED | Pregabalin Then Placebo | 13 | |
| Washout Period | STARTED | Placebo Then Pregabalin | 16 |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 participant flowAdverse events112
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 | Palpitations | Cardiac disorders | Pregabalin | 1 | 28 | |
| other | Palpitations | Cardiac disorders | Placebo | 0 | 30 | |
| other | Vertigo | Ear and labyrinth disorders | Pregabalin | 3 | 28 | |
| other | Vertigo | Ear and labyrinth disorders | Placebo | 1 | 30 | |
| other | Eye pain | Eye disorders | Pregabalin | 0 | 28 | |
| other | Eye pain | Eye disorders | Placebo | 1 | 30 | |
| other | Diplopia | Eye disorders | Pregabalin | 1 | 28 | |
| other | Diplopia | Eye disorders | Placebo | 0 | 30 | |
| other | Vision blurred | Eye disorders | Pregabalin | 2 | 28 | |
| other | Vision blurred | Eye disorders | Placebo | 0 | 30 |
1 to 10 of 112Source ClinicalTrials.gov
See all 112 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Pregabalin | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Pregabalin | 20 | 28 |
| Total, other adverse events | Placebo | 15 | 30 |
| Total, serious adverse events | Pregabalin | 1 | 28 |
| Total, serious adverse events | Placebo | 1 | 30 |
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Pregabalin vs Placebo: serious adverse events |
Source 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/NCT01117766
GET https://conductscience.org/api/trials/v1/NCT01117766/results?page=2