Trial · NCT00617461
A Clinical Study in Subjects With Neuropathic Pain From PHN Who Have Had an Inadequate Response to Gabapentin Treatment
NCT00617461, Phase 2, Completed, XenoPort, Inc.; results first posted 2011-05-20
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ConductScience Library. A Clinical Study in Subjects With Neuropathic Pain From PHN Who Have Had an Inadequate Response to Gabapentin Treatment. Trials, record NCT00617461. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00617461
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Clinical Study in Subjects With Neuropathic Pain From PHN Who Have Had an Inadequate Response to Gabapentin Treatment
- NCT number
- NCT00617461
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 96 participants, actual
- Lead sponsor
- XenoPort, Inc.
- Conditions
- Neuralgia, Postherpetic
- Interventions
- GEn 1200mg/day, GEn 3600mg/day
- First posted
- 2008-02-18
- Last updated
- 2013-07-22
- Results first posted
- 2011-05-20
Source ClinicalTrials.gov
Registered outcomes18
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 the Last Week of Each Treatment Period Using Last Observation Carried Forward (LOCF) Data | Baseline and End of Treatment (Weeks 4 and 9, representing the last week of each treatment period) | Baseline and end of treatment 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 last 7 days on treatment within each period (end of treatment). Participants rated their API over the preceding 24 hours, using an 11-point PI-Numerical Rating Scale (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 end of treatment minus baseline. Data are summarized by dose, independent of treatment period. |
| Primary | Change From Baseline in the Mean 24-hour Average Pain Intensity (API) Score at the Last Week of Each Treatment Period Using LOCF Data for Each Treatment Period | Baseline and End of Treatment (Weeks 4 and 9, representing the last week of each treatment period) | Baseline and end of treatment 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 last 7 days on treatment within each period (end of treatment). Participants used a hand-held diary to rate their average pain intensity over the preceding 24 hours, using an 11-point 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. The by period summary is provided as a sensitivity analysis for the primary analysis. |
| Secondary | Change From Baseline in the Mean Day-time Average Pain Intensity (API) Score at the Last Week of Each Treatment Period Using LOCF Data | Baseline and End of Treatment (Weeks 4 and 9, representing the last week of each treatment period) | 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 end of treatment scores are as defined for the primary endpoint. Change from baseline is calculated as the end of treatment score minus the baseline score. An ANCOVA with baseline value, BMI, grouped center as covariates was used. Data are summarized by dose, independent of treatment period. |
| Secondary | Change From Baseline in the Mean Day-time Worst Pain Intensity Score at the Last Week of Each Treatment Period Using LOCF Data | Baseline and End of Treatment (Weeks 4 and 9, representing the last week of each treatment period) | Day-time worst pain is defined as the participant's assessment of their worst pain intensity between rising in the morning and going to bed at night. Day-time worst pain was recorded in the evening before bedtime using an 11-point PI-NRS (0=no pain, 10=pain as bad as you can imagine). Baseline and end of treatment scores are as defined for the primary endpoint. Change from baseline is calculated as the end of treatment score minus the baseline score. An ANCOVA with baseline value, BMI, grouped center as covariates was used. Data are summarized by dose, independent of treatment period. |
| Secondary | Change From Baseline in the Mean Current (Evening) Pain Intensity Score at the Last Week of Each Treatment Period Using LOCF Data | Baseline and End of Treatment (Weeks 4 and 9, representing the last week of each treatment period) | 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 end of treatment scores are as defined for the primary endpoint. Change from baseline is calculated as the end of treatment score minus the baseline score. An ANCOVA with baseline value, BMI, grouped center as covariates was used. Data are summarized by dose, independent of treatment period. |
| Secondary | Change From Baseline in the Mean Night-time Average Pain Intensity (API) Score at the Last Week of Each Treatment Period Using LOCF | Baseline and End of Treatment (Weeks 4 and 9, representing the last week of each treatment period) | Night-time is defined as the time between going to bed in the evening and rising in the morning. Participants recorded night-time API on a daily basis in the morning upon wakening using an 11-point PI-NRS (0=no pain, 10=pain as bad as you can imagine). Baseline and end of treatment scores are as defined for the primary endpoint. Change from baseline is calculated as the end of treatment score minus the baseline score. An ANCOVA with baseline value, BMI, grouped center as covariates was used. Data are summarized by dose, independent of treatment period. |
| Secondary | Change From Baseline in the Mean Night-time Worst Pain Intensity Score at the Last Week of Each Treatment Period Using LOCF | Baseline and End of Treatment (Weeks 4 and 9, representing the last week of each treatment period) | Night-time worst pain is defined as the participant's assessment of their worst pain intensity between going to bed and rising in the morning. Participants recorded night-time worst pain in the morning upon wakening using an 11-point PI-NRS (0=no pain, 10=pain as bad as you can imagine). Baseline and end of treatment scores are as defined for primary endpoint. Change from baseline = the end of treatment score minus the baseline score. An ANCOVA with baseline value, BMI, grouped center as covariates was used. Data are summarized by dose, independent of treatment period. |
| Secondary | Change From Baseline in the Mean Current Morning Pain Intensity Score at the Last Week of Each Treatment Period Using LOCF | Baseline and End of Treatment (Weeks 4 and 9, representing the last week of each treatment period) | 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 end of treatment scores are as defined for the primary endpoint. Change from baseline is calculated as the end of treatment score minus the baseline score. An ANCOVA with baseline value, BMI, grouped center as covariates was used. Data are summarized by dose, independent of treatment period. |
| Secondary | Number of Participants Achieving Various Levels of Percent Reduction From Baseline in the Mean 24-hour Average Pain Intensity Score at the Last Week of Each Treatment Period Using LOCF Data | Baseline and End of Treatment (Weeks 4 and 9, representing the last week of each treatment period) | Baseline and end of treatment (EOT) scores are the calculated means of the 24-hour average pain scores for each participant during the last 7 days prior to randomization (Baseline) and the 7 days prior to the last on-treatment completed diary (EOT). Percent reduction from baseline was calculated as the \[(EOT score minus baseline score) divided by the baseline score\], multiplied by 100. The PI-NRS is an 11-point scale (0=no pain, 10=pain as bad as you can imagine) by which a participant assesses their 24-hour average pain intensity. Data are summarized by dose, independent of treatment period. |
| Secondary | Number of Participants Achieving Various Levels of Percent Reduction From Baseline in the Mean 24-hour Average Pain Intensity Score at the Last Week of Each Treatment Period Using LOCF Data by Period | Baseline and End of Treatment (Weeks 4 and 9, representing the last week of each treatment period) | Baseline and end of treatment scores are the calculated means of the 24-hour average pain scores for each participant during the last 7 days prior to randomization (Baseline) and the 7 days prior to the last on-treatment completed diary (end of treatment). Percent reduction from baseline was calculated as the \[(end of treatment score minus the baseline score) divided by the baseline score\], multiplied by 100. The PI-NRS is an 11-point scale (0=no pain, 10=pain as bad as you can imagine) by which a participant assesses their 24-hour average pain intensity. Data are summarized by period. |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 registered outcomesOutcomes18
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 the Last Week of Each Treatment Period Using Last Observation Carried Forward (LOCF) Data | Baseline and End of Treatment (Weeks 4 and 9, representing the last week of each treatment period) | Of the 93 participants in the ITT Population, there were 3 and 8 participants who did not take GEn 1200 and 3600 mg, respectively, in the second period. In addition, 1 participant did not provide post-baseline data for 24-hour API assessments during the GEn 3600mg treatment period, and was therefore not included in this analysis. | points on a scale | LEAST_SQUARES_MEAN |
| PRIMARY | Change From Baseline in the Mean 24-hour Average Pain Intensity (API) Score at the Last Week of Each Treatment Period Using LOCF Data for Each Treatment Period | Baseline and End of Treatment (Weeks 4 and 9, representing the last week of each treatment period) | Of the 93 participants in the ITT Population, there were 3 and 8 participants who did not take GEn 1200 and 3600 mg, respectively, in the second period. In addition, 1 participant did not provide post-baseline data for 24 hour API while taking GEn 3600 mg in the first period, and was therefore not included in this analysis. | points on a scale | MEAN |
| SECONDARY | Change From Baseline in the Mean Day-time Average Pain Intensity (API) Score at the Last Week of Each Treatment Period Using LOCF Data | Baseline and End of Treatment (Weeks 4 and 9, representing the last week of each treatment period) | Of the 93 participants in the ITT Population, there were 3 and 8 participants who did not take GEn 1200 and 3600 mg, respectively, in the second period. In addition, 1 participant did not provide post-baseline data for day-time pain assessments during the GEn 3600 mg treatment period, and was therefore not included in this analysis. | points on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in the Mean Day-time Worst Pain Intensity Score at the Last Week of Each Treatment Period Using LOCF Data | Baseline and End of Treatment (Weeks 4 and 9, representing the last week of each treatment period) | Of the 93 participants in the ITT Population, there were 3 and 8 participants who did not take GEn 1200 and 3600 mg, respectively, in the second period. In addition, 1 participant did not provide post-baseline data for day-time pain assessments during the GEn 3600 mg treatment period, and was therefore not included in this analysis. | points on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in the Mean Current (Evening) Pain Intensity Score at the Last Week of Each Treatment Period Using LOCF Data | Baseline and End of Treatment (Weeks 4 and 9, representing the last week of each treatment period) | Of the 93 participants in the ITT Population, there were 3 and 8 participants who did not take GEn 1200 and 3600 mg, respectively, in the second period. In addition, 1 participant did not provide post-baseline data for current evening pain during the GEn 3600 mg treatment period, and was therefore not included in this analysis. | points on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in the Mean Night-time Average Pain Intensity (API) Score at the Last Week of Each Treatment Period Using LOCF | Baseline and End of Treatment (Weeks 4 and 9, representing the last week of each treatment period) | Of the 93 participants in the ITT Population, there were 3 and 8 participants who did not take GEn 1200 and 3600 mg, respectively, in the second period. In addition, 1 participant did not provide post-baseline data for night-time pain assessments during the GEn 1200 mg treatment period, and was therefore not included in this analysis. | points on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in the Mean Night-time Worst Pain Intensity Score at the Last Week of Each Treatment Period Using LOCF | Baseline and End of Treatment (Weeks 4 and 9, representing the last week of each treatment period) | Of the 93 participants in the ITT Population, there were 3 and 8 participants who did not take GEn 1200 and 3600 mg, respectively, in the second period. In addition, 1 participant did not provide post-baseline data for night-time pain assessments during the GEn 1200 mg treatment period, and was therefore not included in this analysis. | points on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in the Mean Current Morning Pain Intensity Score at the Last Week of Each Treatment Period Using LOCF | Baseline and End of Treatment (Weeks 4 and 9, representing the last week of each treatment period) | Of the 93 participants in the ITT Population, there were 3 and 8 participants who did not take GEn 1200 and 3600 mg, respectively, in the second period. In addition, 1 participant did not provide post-baseline data for current morning pain during the GEn 1200 mg treatment period, and was therefore not included in this analysis. | points on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Participants Achieving Various Levels of Percent Reduction From Baseline in the Mean 24-hour Average Pain Intensity Score at the Last Week of Each Treatment Period Using LOCF Data | Baseline and End of Treatment (Weeks 4 and 9, representing the last week of each treatment period) | Of the 93 participants in the ITT Population, there were 3 and 8 participants who did not take GEn 1200 and 3600 mg, respectively, in the second period. In addition, there was one participant who did not provide post-baseline data for 24-hour API assessments during the GEn 3600 mg treatment period, and was therefore not included in this analysis. | participants | NUMBER |
| SECONDARY | Number of Participants Achieving Various Levels of Percent Reduction From Baseline in the Mean 24-hour Average Pain Intensity Score at the Last Week of Each Treatment Period Using LOCF Data by Period | Baseline and End of Treatment (Weeks 4 and 9, representing the last week of each treatment period) | Of the 93 participants in the ITT Population, there were 3 and 8 participants who did not take GEn 1200 and 3600 mg, respectively, in the second period. In addition, there was one participant who did not provide post-baseline data for 24-hour API while taking GEn 3600 mg in the first period, and was therefore not included in this analysis. | participants | NUMBER |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 outcomesResults by group113
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 the Last Week of Each Treatment Period Using Last Observation Carried Forward (LOCF) Data | GEn 1200 mg | -1.18 | Standard Error 0.171 | points on a scale | |
| Change From Baseline in the Mean 24-hour Average Pain Intensity (API) Score at the Last Week of Each Treatment Period Using Last Observation Carried Forward (LOCF) Data | GEn 3600 mg | -1.47 | Standard Error 0.173 | points on a scale | |
| Change From Baseline in the Mean 24-hour Average Pain Intensity (API) Score at the Last Week of Each Treatment Period Using LOCF Data for Each Treatment Period | GEn 1200 mg in First Intervention Period | -1.11 | Standard Deviation 1.477 | points on a scale | |
| Change From Baseline in the Mean 24-hour Average Pain Intensity (API) Score at the Last Week of Each Treatment Period Using LOCF Data for Each Treatment Period | GEn 3600 mg in First Intervention Period | -1.09 | Standard Deviation 1.366 | points on a scale | |
| Change From Baseline in the Mean 24-hour Average Pain Intensity (API) Score at the Last Week of Each Treatment Period Using LOCF Data for Each Treatment Period | GEn 1200 mg in Second Intervention Period | -1.29 | Standard Deviation 1.742 | points on a scale | |
| Change From Baseline in the Mean 24-hour Average Pain Intensity (API) Score at the Last Week of Each Treatment Period Using LOCF Data for Each Treatment Period | GEn 3600 mg in Second Interevention Period | -1.92 | Standard Deviation 2.000 | points on a scale | |
| Change From Baseline in the Mean Day-time Average Pain Intensity (API) Score at the Last Week of Each Treatment Period Using LOCF Data | GEn 1200 mg | -1.17 | Standard Error 0.172 | points on a scale | |
| Change From Baseline in the Mean Day-time Average Pain Intensity (API) Score at the Last Week of Each Treatment Period Using LOCF Data | GEn 3600 mg | -1.48 | Standard Error 0.174 | points on a scale | |
| Change From Baseline in the Mean Day-time Worst Pain Intensity Score at the Last Week of Each Treatment Period Using LOCF Data | GEn 1200 mg | -1.17 | Standard Error 0.178 | points on a scale | |
| Change From Baseline in the Mean Day-time Worst Pain Intensity Score at the Last Week of Each Treatment Period Using LOCF Data | GEn 3600 mg | -1.50 | Standard Error 0.181 | points on a scale |
1 to 10 of 113Source ClinicalTrials.gov
See all 113 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| First Treatment Intervention Period | STARTED | GEn 1200 mg/Day Followed by GEn 3600 mg/Day | 52 | |
| First Treatment Intervention Period | STARTED | GEn 3600 mg/Day Followed by GEn 1200 mg/Day | 44 | |
| First Treatment Intervention Period | COMPLETED | GEn 1200 mg/Day Followed by GEn 3600 mg/Day | 42 | |
| First Treatment Intervention Period | COMPLETED | GEn 3600 mg/Day Followed by GEn 1200 mg/Day | 41 | |
| First Treatment Intervention Period | NOT COMPLETED | GEn 1200 mg/Day Followed by GEn 3600 mg/Day | 10 | |
| First Treatment Intervention Period | NOT COMPLETED | GEn 3600 mg/Day Followed by GEn 1200 mg/Day | 3 | |
| 4-Day Crossover Period | STARTED | GEn 1200 mg/Day Followed by GEn 3600 mg/Day | 42 | |
| 4-Day Crossover Period | STARTED | GEn 3600 mg/Day Followed by GEn 1200 mg/Day | 40 | |
| 4-Day Crossover Period | COMPLETED | GEn 1200 mg/Day Followed by GEn 3600 mg/Day | 41 | |
| 4-Day Crossover Period | COMPLETED | GEn 3600 mg/Day Followed by GEn 1200 mg/Day | 40 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events114
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 | Nasopharyngitis | Infections and infestations | Baseline Gabapentin 1800 mg | 0 | 94 | |
| other | Nasopharyngitis | Infections and infestations | GEn 1200 mg | 4 | 91 | |
| other | Nasopharyngitis | Infections and infestations | Crossover GEn 2400 mg | 0 | 82 | |
| other | Nasopharyngitis | Infections and infestations | GEn 3600 mg | 1 | 85 | |
| other | Nasopharyngitis | Infections and infestations | Down-Titration Period | 0 | 80 | |
| other | Nasopharyngitis | Infections and infestations | Overall GEn | 5 | 94 | |
| other | Headache | Nervous system disorders | Baseline Gabapentin 1800 mg | 1 | 94 | |
| other | Headache | Nervous system disorders | GEn 1200 mg | 1 | 91 | |
| other | Headache | Nervous system disorders | Crossover GEn 2400 mg | 0 | 82 | |
| other | Headache | Nervous system disorders | GEn 3600 mg | 3 | 85 |
1 to 10 of 114Source ClinicalTrials.gov
See all 114 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Baseline Gabapentin 1800 mg | ||
| Total, all-cause mortality | GEn 1200 mg | ||
| Total, all-cause mortality | Crossover GEn 2400 mg | ||
| Total, all-cause mortality | GEn 3600 mg | ||
| Total, all-cause mortality | Down-Titration Period | ||
| Total, all-cause mortality | Overall GEn | ||
| Total, other adverse events | Baseline Gabapentin 1800 mg | 2 | 94 |
| Total, other adverse events | GEn 1200 mg | 15 | 91 |
| Total, other adverse events | Crossover GEn 2400 mg | 3 | 82 |
| Total, other adverse events | GEn 3600 mg | 14 | 85 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 24102928 | 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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| GEn 1200 mg vs GEn 3600 mg: Number of Participants Who Are Responders on the Patient Global Impression of Change (PGIC) at the Last Week of Each Treatment Period Using LOCF Data | Trial comparisons |
| GEn 1200 mg vs GEn 3600 mg: Number of Participants Who Are Responders on the Clinical Global Impression of Change (CGIC) Questionnaire at the Last Week of Each Treatment Period Using LOCF Data | 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.
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