Trial · NCT00643760
A Study In Patients With Neuropathic Pain From Diabetic Peripheral Neuropathy (DPN)
NCT00643760, Phase 2, Completed, XenoPort, Inc.; results first posted 2011-05-11
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study In Patients With Neuropathic Pain From Diabetic Peripheral Neuropathy (DPN). Trials, record NCT00643760. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00643760
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study In Patients With Neuropathic Pain From Diabetic Peripheral Neuropathy (DPN)
- NCT number
- NCT00643760
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 421 participants, actual
- Lead sponsor
- XenoPort, Inc.
- Conditions
- Neuropathy, Diabetic
- Interventions
- Placebo, GEn 1200mg/day, GEn 2400mg/day, GEn 3600mg/day, Pregabalin
- First posted
- 2008-03-26
- Last updated
- 2013-07-22
- Results first posted
- 2011-05-11
Source ClinicalTrials.gov
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in the Mean 24-hour Average Pain Intensity (API) Score at End of Maintenance Treatment (EOMT) Using Last Observation Carried Forward (LOCF) Data | Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit) | Baseline and EOMT values are the calculated means of the daily 24-hour API scores for each participant during the last 7 days prior to randomization (Baseline) and the earliest date of Week 13 visit/Withdrawal visit/last dose of study drug (EOMT). Participants used a hand-held diary to rate their API over the preceding 24 hours, using an 11-point Pain Intensity Numerical Rating Scale (PI-NRS) (0=no pain, 10=pain as bad as you can imagine). LOCF was used if less than 4 days of diary data were provided. Change from baseline was calculated as the EOMT score minus the Baseline score. |
| Secondary | Change From Baseline in the Mean Day-time Average Pain Intensity (API) Score at EOMT Using LOCF Data | Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit) | Day-time is defined as the time between rising in the morning and going to bed at night. Participants recorded day-time API on a daily basis in the evening before bedtime using an 11-point PI-NRS (0=no pain, 10=pain as bad as you can imagine). Baseline and EOMT are as defined for the primary endpoint. Change from baseline was calculated as the EOMT score minus the baseline score. An ANCOVA model with baseline value, BMI, grouped center as covariates was used. |
| Secondary | Change From Baseline in the Mean Night-time Average Pain Intensity (API) Score at EOMT Using LOCF Data | Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit) | Night-time is defined as the time between going to bed at night and rising in the morning. Participants recorded night-time API on a daily basis in the morning upon awakening using an 11-point PI-NRS (0=no pain, 10=pain as bad as you can imagine). Baseline and EOMT are as defined for the primary endpoint. Change from baseline was calculated as the EOMT score minus the baseline score. An ANCOVA model with baseline value, BMI, grouped center as covariates was used. |
| Secondary | Change From Baseline in the Mean Current (Morning) Pain Intensity Score at EOMT Using LOCF Data | Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit) | Current pain is defined as the participant's assessment of pain intensity "right now." Participants recorded their current morning pain intensity in the morning upon wakening using an 11-point PI-NRS (0=no pain, 10=pain as bad as you can imagine). Baseline and EOMT are as defined for the primary endpoint. Change from baseline was calculated as the EOMT score minus the baseline score. An ANCOVA model with baseline value, BMI, grouped center as covariates was used. |
| Secondary | Change From Baseline in the Mean Current (Evening) Pain Intensity Score at EOMT Using LOCF Data | Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit) | Current pain is defined as the participant's assessment of pain intensity "right now." Participants recorded their current evening pain intensity in the evening before bedtime using an 11-point PI-NRS (0=no pain, 10=pain as bad as you can imagine). Baseline and EOMT are as defined for the primary endpoint. Change from baseline was calculated as the EOMT score minus the baseline score. An ANCOVA model with baseline value, BMI, grouped center as covariates was used. |
| Secondary | Change From Baseline in the Mean Day-time Worst Pain Intensity Score at EOMT Using LOCF Data | Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit) | Day-time worst pain is defined as the partipant's assessment of their worst pain between rising in the morning and going to bed at night. Participants recorded day-time worst pain in the evening before bedtime using an 11-point PI-NRS (0=no pain, 10=pain as bad as you can imagine). Baseline and EOMT are as defined for the primary endpoint. Change from baseline was calculated as the EOMT score minus the baseline score. An ANCOVA model with baseline value, BMI, grouped center as covariates was used. |
| Secondary | Change From Baseline in the Mean Night-time Worst Pain Intensity Score at EOMT Using LOCF Data | Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit) | Night-time worst pain is defined as the partipant's assessment of their worst pain between going to bed at night and rising in the morning. Participants recorded night-time worst pain in the morning upon awakening using an 11-point PI-NRS (0=no pain, 10=pain as bad as you can imagine). Baseline and EOMT are as defined for the primary endpoint. Change from baseline was calculated as the EOMT score minus the baseline score. An ANCOVA model with baseline value, BMI, grouped center as covariates was used. |
| Secondary | Change From Baseline in the Mean Sleep Interference Score at EOMT Using LOCF Data | Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit) | Participants assessed sleep interference due to pain on a daily basis in the morning upon awakening using an 11-point NRS (0=pain does not interfere with sleep, 10=pain completely interferes with sleep). Baseline and EOMT are as defined for the primary endpoint. Change from baseline was calculated as the EOMT score minus the baseline score. An ANCOVA model with baseline value, BMI, grouped center as covariates was used. |
| Secondary | Change From Baseline in the Mean Daily Dose of Rescue Medication at EOMT Using LOCF Data | Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit) | Mean daily use of rescue medication (milligrams of acetaminophen) was calculated by determining the average number of tablets taken per day of rescue medication (Commerical Tylenol) during treatment and multiplying that by 500 mg. Baseline and EOMT are as defined for the primary endpoint. Change from baseline was calculated as the EOMT score minus the baseline score. An ANCOVA model with baseline value, BMI, grouped center as covariates was used. |
| Secondary | Change From Baseline in Pain Quality as Assessed by the Neuropathic Pain Scale (NPS) Summary Scores at EOMT Using LOCF Data | Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit) | The NPS assesses pain qualities and consists of 11-items, 10 assessed on an 11-point NRS (0=no impact to 10=greatest impact); and 1 open-ended question not used in score calculation. 4 summary scores are calculated: NPS 10 (items 1-7, 9-11), NPS 8 (8 pain descriptor items), NPS Non-Allodynic (NA) (8 NA items), and NPS 4 (4 pain quality items); and range from 0 to 100 (0=no impact and 100=greatest impact). The analysis is based on the change from baseline (BL) (EOMT score minus the BL score) using an ANCOVA model with BL value, BMI, grouped center as covariates. |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 registered outcomesOutcomes19
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in the Mean 24-hour Average Pain Intensity (API) Score at End of Maintenance Treatment (EOMT) Using Last Observation Carried Forward (LOCF) Data | Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit) | ITT Population | scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in the Mean Day-time Average Pain Intensity (API) Score at EOMT Using LOCF Data | Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit) | ITT Population | scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in the Mean Night-time Average Pain Intensity (API) Score at EOMT Using LOCF Data | Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit) | ITT Population. There were two participants in the GEn 3600 mg/day group who did not complete enough post-baseline morning diaries to calculate an average night-time pain intensity score for the EOMT timepoint. | scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in the Mean Current (Morning) Pain Intensity Score at EOMT Using LOCF Data | Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit) | ITT Population. There were two participants in the GEn 3600 mg/day group who did not complete enough post-baseline morning diaries to calculate a current (morning) pain intensity score for the EOMT timepoint. | scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in the Mean Current (Evening) Pain Intensity Score at EOMT Using LOCF Data | Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit) | ITT Population | scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in the Mean Day-time Worst Pain Intensity Score at EOMT Using LOCF Data | Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit) | ITT Population | scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in the Mean Night-time Worst Pain Intensity Score at EOMT Using LOCF Data | Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit) | ITT Population. There were two participants in the GEn 3600 mg/day group who did not complete enough post-baseline morning diaries to calculate a night-time worst pain intensity score for the EOMT timepoint. | scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in the Mean Sleep Interference Score at EOMT Using LOCF Data | Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit) | ITT Population. There were two participants in the GEn 3600 mg/day group who did not complete enough post-baseline morning diaries to calculate a night-time worst pain intensity score for the EOMT timepoint. | scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in the Mean Daily Dose of Rescue Medication at EOMT Using LOCF Data | Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit) | ITT Population | milligrams | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Pain Quality as Assessed by the Neuropathic Pain Scale (NPS) Summary Scores at EOMT Using LOCF Data | Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit) | ITT Population. Not all participants completed an NPS assessment at both Baseline and Week 13/Withdrawal; as such, the number analyzed is different from the full ITT Population counts. | scores on a scale | LEAST_SQUARES_MEAN |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 outcomesResults by group205
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in the Mean 24-hour Average Pain Intensity (API) Score at End of Maintenance Treatment (EOMT) Using Last Observation Carried Forward (LOCF) Data | Placebo | -2.08 | Standard Error 0.196 | scores on a scale | |
| Change From Baseline in the Mean 24-hour Average Pain Intensity (API) Score at End of Maintenance Treatment (EOMT) Using Last Observation Carried Forward (LOCF) Data | GEn 1200 mg/Day | -2.43 | Standard Error 0.274 | scores on a scale | |
| Change From Baseline in the Mean 24-hour Average Pain Intensity (API) Score at End of Maintenance Treatment (EOMT) Using Last Observation Carried Forward (LOCF) Data | GEn 2400 mg/Day | -2.10 | Standard Error 0.289 | scores on a scale | |
| Change From Baseline in the Mean 24-hour Average Pain Intensity (API) Score at End of Maintenance Treatment (EOMT) Using Last Observation Carried Forward (LOCF) Data | GEn 3600 mg/Day | -2.63 | Standard Error 0.202 | scores on a scale | |
| Change From Baseline in the Mean 24-hour Average Pain Intensity (API) Score at End of Maintenance Treatment (EOMT) Using Last Observation Carried Forward (LOCF) Data | PGB 300 mg/Day | -1.65 | Standard Error 0.266 | scores on a scale | |
| Change From Baseline in the Mean Day-time Average Pain Intensity (API) Score at EOMT Using LOCF Data | Placebo | -2.07 | Standard Error 0.195 | scores on a scale | |
| Change From Baseline in the Mean Day-time Average Pain Intensity (API) Score at EOMT Using LOCF Data | GEn 1200 mg/Day | -2.35 | Standard Error 0.272 | scores on a scale | |
| Change From Baseline in the Mean Day-time Average Pain Intensity (API) Score at EOMT Using LOCF Data | GEn 2400 mg/Day | -2.06 | Standard Error 0.286 | scores on a scale | |
| Change From Baseline in the Mean Day-time Average Pain Intensity (API) Score at EOMT Using LOCF Data | GEn 3600 mg/Day | -2.54 | Standard Error 0.200 | scores on a scale | |
| Change From Baseline in the Mean Day-time Average Pain Intensity (API) Score at EOMT Using LOCF Data | PGB 300 mg/Day | -1.50 | Standard Error 0.264 | scores on a scale |
1 to 10 of 205Source ClinicalTrials.gov
See all 205 results by groupParticipant flow25
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 120 | |
| Overall Study | STARTED | GEn 1200 mg/Day | 62 | |
| Overall Study | STARTED | GEn 2400 mg/Day | 56 | |
| Overall Study | STARTED | GEn 3600 mg/Day | 117 | |
| Overall Study | STARTED | PGB 300 mg/Day | 66 | |
| Overall Study | Safety Population/Treated With Drug | Placebo | 120 | |
| Overall Study | Safety Population/Treated With Drug | GEn 1200 mg/Day | 62 | |
| Overall Study | Safety Population/Treated With Drug | GEn 2400 mg/Day | 56 | |
| Overall Study | Safety Population/Treated With Drug | GEn 3600 mg/Day | 116 | |
| Overall Study | Safety Population/Treated With Drug | PGB 300 mg/Day | 66 |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 participant flowAdverse events245
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 | Placebo | 6 | 120 | |
| other | Dizziness | Nervous system disorders | GEn 1200 mg/Day | 9 | 62 | |
| other | Dizziness | Nervous system disorders | GEn 2400 mg/Day | 8 | 56 | |
| other | Dizziness | Nervous system disorders | GEn 3600 mg/Day | 16 | 116 | |
| other | Dizziness | Nervous system disorders | PGB 300 mg/Day | 9 | 66 | |
| other | Somnolence | Nervous system disorders | Placebo | 5 | 120 | |
| other | Somnolence | Nervous system disorders | GEn 1200 mg/Day | 2 | 62 | |
| other | Somnolence | Nervous system disorders | GEn 2400 mg/Day | 7 | 56 | |
| other | Somnolence | Nervous system disorders | GEn 3600 mg/Day | 14 | 116 | |
| other | Somnolence | Nervous system disorders | PGB 300 mg/Day | 9 | 66 |
1 to 10 of 245Source ClinicalTrials.gov
See all 245 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | GEn 1200 mg/Day | ||
| Total, all-cause mortality | GEn 2400 mg/Day | ||
| Total, all-cause mortality | GEn 3600 mg/Day | ||
| Total, all-cause mortality | PGB 300 mg/Day | ||
| Total, other adverse events | Placebo | 50 | 120 |
| Total, other adverse events | GEn 1200 mg/Day | 34 | 62 |
| Total, other adverse events | GEn 2400 mg/Day | 25 | 56 |
| Total, other adverse events | GEn 3600 mg/Day | 62 | 116 |
| Total, other adverse events | PGB 300 mg/Day | 32 | 66 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 23186035 | 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
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/NCT00643760
GET https://conductscience.org/api/trials/v1/NCT00643760/results?page=2