Trial · NCT00617461
Outcomes18
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 18 of 18
Download this page as JSON| 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 |
| SECONDARY | Change From Baseline in the Mean Daily Dose in Milligrams of Rescue Medication at the Last Week of 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, there was one participant who did not provide post-baseline data for rescue medication usage during the GEn 3600 mg treatment period, and was therefore not included in this analysis. | milligrams | LEAST_SQUARES_MEAN |
| SECONDARY | 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 | End of Treatment (Weeks 4 and 9, representing the last week of each treatment period) | ITT Population. There were 3 and 8 participants who did not take GEn 1200 and 3600 mg, respectively, in the second period. There were many participants who did not respond to the questionnaire and thus could not be included in the analysis. | participants | NUMBER |
| SECONDARY | Number of Participants Who Are Responders on the Patient Global Impression of Change (PGIC) Questionnaire at the Last Week of Each Treatment Period Presented by Period Using LOCF Data | End of Treatment (Weeks 4 and 9, representing the last week of each treatment period) | ITT Population. There were 3 and 8 participants who did not take GEn 1200 and 3600 mg, respectively, in the second period. There were many participants who did not respond to the questionnaire and thus could not be included in the analysis. | participants | NUMBER |
| SECONDARY | 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 | End of Treatment (Weeks 4 and 9, representing the last week of each treatment period) | ITT Population. There were 3 and 8 participants who did not take GEn 1200 and 3600 mg, respectively, in the second period. There were many participants without a response to this questionnaire and thus could not be included in the analysis. | participants | NUMBER |
| SECONDARY | Number of Participants Who Are Responders on the Clinical Global Impression of Change (CGIC) Questionnaire at the Last Week of Each Treatment Period Presented by Period Using LOCF Data | End of Treatment (Weeks 4 and 9, representing the last week of each treatment period) | ITT Population. There were 3 and 8 participants who did not take GEn 1200 and 3600 mg, respectively, in the second period. There were many participants without a response data to this questionnaire and could thus not be included in the analysis. | participants | NUMBER |
| SECONDARY | Change From Baseline in the Mean Sleep Interference 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 sleep interference 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 Severity of Pain and the Impact of Pain as Assessed by the Brief Pain Inventory (BPI) at the Last Week of Each Treatment Period Using LOCF | Baseline and End of Treatment (Weeks 4 and 9, representing the last week of treatment) | ITT Population. There were 3 and 8 participants who did not take GEn 1200 and 3600 mg, respectively, in the second period. There were many participants who did not respond to the questionnaire and could thus not be included in the analysis. | points on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Gabapentin Steady-State (ss) Average, Minimum and Maximum Concentrations | A total of 10 blood samples (2 samples at each visit) were collected per participant at Baseline, and the Week 1 and Week 4 visits for each period | Drug concentration data were available from 89 ITT Population participants. Data from 7 of these participants had one concentration with less than half of the first percentile of the concentrations observed at ss and were defined as non-compliant and were excluded from the pharmacokinetic (PK) analysis. | micrograms per milliliter | GEOMETRIC_MEAN |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
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