Trial · NCT00654940
A Study To Assess The Ability Of A Crossover Study Design To Detect The Efficacy Of Pregabalin In Post-Traumatic Neuropathic Pain Patients
NCT00654940, Phase 1, Completed, Pfizer's Upjohn has merged with Mylan to form Viatris Inc.; results first posted 2010-02-24
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study To Assess The Ability Of A Crossover Study Design To Detect The Efficacy Of Pregabalin In Post-Traumatic Neuropathic Pain Patients. Trials, record NCT00654940. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00654940
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study To Assess The Ability Of A Crossover Study Design To Detect The Efficacy Of Pregabalin In Post-Traumatic Neuropathic Pain Patients
- NCT number
- NCT00654940
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 25 participants, actual
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Conditions
- Nerve Pain
- Interventions
- Pregabalin (Lyrica), Placebo
- First posted
- 2008-04-09
- Last updated
- 2021-02-09
- Results first posted
- 2010-02-24
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline to Treatment Week 2 in Daily Pain Rating Scale | Week 0 to Week 2, Week 4 to Week 6 (Baseline to Week 2 [End of Treatment] for each treatment period) | Daily Pain Rating Scale by treatment and sequence using an 11-point Likert scale: range 0 (no pain) to 10 (worst possible pain) over the past 24 hours. Self-assessment was performed daily on rising from bed (for the final time in the case of interrupted sleep). Average daily pain score: mean of the previous 7 days daily pain scores. Baseline was defined as the mean of the last 7 pre-treatment pain scores for each period. End of treatment was defined as the mean of the last 7 on treatment pain scores for each period. |
| Secondary | Neuropathic Pain Symptom Inventory (NPSI) | Week 0 to Week 2, Week 4 to Week 6 (Baseline to End of Treatment in Treatment Periods 1 and 2) | NPSI at end of treatment: 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. |
| Secondary | Subject Activity as Captured by the Actiwatch Score Device: Total Activity Score at End of Treatment | Week 0 to Week 2, Week 4 to Week 6 (Baseline to End of Treatment in Treatment Periods 1 and 2) | Total activity score: Day (8 am to 8 pm) at end of treatment. Accelerometer measured physical activity by monitoring degree and intensity of body motion. Data is reported as activity counts. Subject activity was collected hourly for the variables: peak, average, and total activity. Higher score indicates greater activity (no activity = 0; total possible score was not defined). |
Source ClinicalTrials.gov
Outcomes3
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 Treatment Week 2 in Daily Pain Rating Scale | Week 0 to Week 2, Week 4 to Week 6 (Baseline to Week 2 [End of Treatment] for each treatment period) | Full Analysis Set: (FAS): all subjects randomized who received at least one dose of study drug, regardless of whether they had efficacy data. Baseline is Week 0 and Week 4 for Periods 1 and 2, respectively. Treatment Week 2 is End of Treatment (Week 2 and Week 6) for Periods 1 and 2, respectively. | scores on scale | MEAN |
| SECONDARY | Neuropathic Pain Symptom Inventory (NPSI) | Week 0 to Week 2, Week 4 to Week 6 (Baseline to End of Treatment in Treatment Periods 1 and 2) | FAS. Weeks 0 and 4 are baseline for Periods 1 and 2, respectively. Weeks 2 and 6 are End of Treatment for Periods 1 and 2, respectively. | scores on scale | MEAN |
| SECONDARY | Subject Activity as Captured by the Actiwatch Score Device: Total Activity Score at End of Treatment | Week 0 to Week 2, Week 4 to Week 6 (Baseline to End of Treatment in Treatment Periods 1 and 2) | FAS; End of Treatment is treatment week 2 (Week 2 and Week 6) for Periods 1 and 2. | scores on scale | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group22
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 Treatment Week 2 in Daily Pain Rating Scale | Period 1: Pregabalin | Baseline | 6.03 | Standard Deviation 1.29 | scores on scale |
| Change From Baseline to Treatment Week 2 in Daily Pain Rating Scale | Period 1: Placebo | Baseline | 5.24 | Standard Deviation 2.03 | scores on scale |
| Change From Baseline to Treatment Week 2 in Daily Pain Rating Scale | Period 2: Placebo | Baseline | 5.96 | Standard Deviation 0.88 | scores on scale |
| Change From Baseline to Treatment Week 2 in Daily Pain Rating Scale | Period 2: Pregabalin | Baseline | 5.31 | Standard Deviation 1.82 | scores on scale |
| Change From Baseline to Treatment Week 2 in Daily Pain Rating Scale | Period 1: Pregabalin | Treatment Week 2 | 5.40 | Standard Deviation 1.34 | scores on scale |
| Change From Baseline to Treatment Week 2 in Daily Pain Rating Scale | Period 1: Placebo | Treatment Week 2 | 5.08 | Standard Deviation 2.05 | scores on scale |
| Change From Baseline to Treatment Week 2 in Daily Pain Rating Scale | Period 2: Placebo | Treatment Week 2 | 6.11 | Standard Deviation 1.20 | scores on scale |
| Change From Baseline to Treatment Week 2 in Daily Pain Rating Scale | Period 2: Pregabalin | Treatment Week 2 | 4.38 | Standard Deviation 2.02 | scores on scale |
| Change From Baseline to Treatment Week 2 in Daily Pain Rating Scale | Period 1: Pregabalin | Change from Baseline | -0.63 | Standard Deviation 1.01 | scores on scale |
| Change From Baseline to Treatment Week 2 in Daily Pain Rating Scale | Period 1: Placebo | Change from Baseline | -0.16 | Standard Deviation 0.97 | scores on scale |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 results by groupParticipant flow20
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Period 1 | STARTED | Pregabalin First Then Placebo | 13 | |
| Period 1 | STARTED | Placebo First Then Pregabalin | 12 | |
| Period 1 | Received Study Treatment | Pregabalin First Then Placebo | 12 | |
| Period 1 | Received Study Treatment | Placebo First Then Pregabalin | 12 | |
| Period 1 | COMPLETED | Pregabalin First Then Placebo | 12 | |
| Period 1 | COMPLETED | Placebo First Then Pregabalin | 11 | |
| Period 1 | NOT COMPLETED | Pregabalin First Then Placebo | 1 | |
| Period 1 | NOT COMPLETED | Placebo First Then Pregabalin | 1 | |
| Washout Period of 2 Weeks | STARTED | Pregabalin First Then Placebo | 12 | |
| Washout Period of 2 Weeks | STARTED | Placebo First Then Pregabalin | 11 |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 participant flowAdverse events60
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 | Vertigo | Ear and labyrinth disorders | Pregabalin | 0 | 24 | |
| other | Vertigo | Ear and labyrinth disorders | Placebo | 1 | 24 | |
| other | Eye disorder | Eye disorders | Pregabalin | 1 | 24 | |
| other | Eye disorder | Eye disorders | Placebo | 0 | 24 | |
| other | Vision blurred | Eye disorders | Pregabalin | 1 | 24 | |
| other | Vision blurred | Eye disorders | Placebo | 1 | 24 | |
| other | Abdominal pain | Gastrointestinal disorders | Pregabalin | 0 | 24 | |
| other | Abdominal pain | Gastrointestinal disorders | Placebo | 1 | 24 | |
| other | Dry mouth | Gastrointestinal disorders | Pregabalin | 2 | 24 | |
| other | Dry mouth | Gastrointestinal disorders | Placebo | 1 | 24 |
1 to 10 of 60Source ClinicalTrials.gov
See all 60 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 | 11 | 24 |
| Total, other adverse events | Placebo | 10 | 24 |
| Total, serious adverse events | Pregabalin | 0 | 24 |
| Total, serious adverse events | Placebo | 0 | 24 |
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/NCT00654940
GET https://conductscience.org/api/trials/v1/NCT00654940/results?page=2