Trial · NCT00619476
Outcomes19
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 19 of 19
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 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: all randomized participants who took at least one dose of investigational product and provided at least one post-baseline efficacy measurement. | points 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 was one participant in the GEn 2400 mg group and one in the 3600 mg group who did not complete enough post-baseline morning diaries to calculate an API for the EOMT timepoint. | points 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 was one participant in the GEn 2400 mg group and one in the 3600 mg group who did not complete enough post-baseline morning diaries to calculate an API for the EMOT timepoint. | points 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 was one participant in the GEn 2400 mg group and one in the 3600 mg group who did not complete enough post-baseline morning diaries to calculate an API for the EMOT timepoint. | points 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 was one participant in the GEn 2400 mg group and one in the 3600 mg group who did not complete enough post-baseline morning diaries to calculate a score for the EMOT timepoint. | points 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. There was one participant in the GEn 1200 mg group and two in the 2400 mg group who did not complete enough post-baseline evening diaries to calculate an API for the EOMT timepoint. | points 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. There was one participant in the GEn 1200 mg group and two in the 2400 mg group who did not complete enough post-baseline evening diaries to calculate a score for the EMOT timepoint. | points 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. There was one participant in the GEn 1220 mg group and two in the 2400 mg group who did not complete enough post-baseline evening diaries to calculate a score for the EOMT timepoint. | points on a scale | 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. The NPS summary included a subset of the ITT Population that completed an NPS assessment at both Baseline and Week 13/Withdrawal. | points on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Pain Characteristics and Intensity as Assessed by the Short Form-McGill Pain Questionnaire (SF-MPQ) at EOMT Using LOCF Data | Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit) | ITT Population. The SF-MPQ analysis included a subset of the ITT Population who completed a SF-MPQ assessment at both Baseline and the Week 13/Withdrawal Visit. | points on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Dynamic Allodynia at EOMT Using LOCF Data | Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit) | ITT Population. The NRS analysis included a subset of the ITT Population who completed that NRS at both the Baseline and the Week13/Withdrawal Visit. | points on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Participants Who Are Responders on the Patient Global Impression of Change (PGIC) Questionnaire at EOMT Using LOCF Data | EOMT (representing the earliest date of Week 13 visit/withdrawal visit) | ITT Population. The PGIC analysis included a subset of the ITT Population who completed the PGIC questionnaire at the end of treatment. | participants | NUMBER |
| SECONDARY | Number of Participants Achieving Various Levels of Percent Reduction From Baseline in the Mean 24-hour Average Pain Intensity Score at EOMT Using LOCF Data | Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit) | ITT Population. There was one participant in the GEn 1200 mg and one in the GEn 2400 mg group who did not have enough data available to calculate the percent reduction. | participants | NUMBER |
| SECONDARY | Time to Onset of Sustained Improvement in the 24-hour Average Pain Intensity Score | Anytime post-baseline until date of last dose of study medication (up to Week 13) | ITT Population | days | MEDIAN |
| SECONDARY | Change From Baseline in the Mean Daily Dose in Milligrams of Rescue Medication at EOMT Using LOCF Data | Baseline and EOMT (Week 13 or early withdrawal) | ITT Population. There was one participant in the GEn 1200 mg and two in the GEn 2400 mg group who did not have enough data available to calculate the rescue mediation consumed while on treatment. | milligrams | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Severity of Pain and the Impact of Pain as Assessed by the Brief Pain Inventory (BPI) at EOMT Using LOCF Data | Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit) | ITT Population. Not all participants completed a BPI assessment at both Baseline and Week 13/Withdrawal; as such, the number analyzed is different from the full ITT Population counts. | points on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Quality of Life as Assessed by the SF-36 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 SF-36 at both Baseline and Week 13/Withdrawal; as such, the number analyzed is different from the full ITT Population counts. | points on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Emotional Functioning as Assessed by the POMS-B at EOMT Using LOCF Data | Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit) | ITT Population. Not all participants completed a POMS-B at both Baseline and Week 13/Withdrawal; as such, the number analyzed is different from the full ITT Population counts. | points on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Participants Who Are Responders on the Clinician Global Impression of Change (CGIC) Questionnaire at EOMT Using LOCF Data | EOMT (representing the earliest date of Week 13 visit/withdrawal visit) | ITT Population. The CGIC analysis included a subset of the ITT Population who completed the PGIC questionnaire at the end of treatment. | participants | NUMBER |
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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