Trial · NCT00643760
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 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 |
| 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. Not all participants completed an SF-MPQ 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 |
| SECONDARY | Change From Baseline in Pain Score After Taking a 50-foot Walk at EOMT | Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit) | ITT Population. Not all participants completed a 50-foot walk 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 |
| 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. Not all participants completed a PGIC assessment at Week 13/Withdrawal; as such, the number analyzed is different from the full ITT Population counts. | participants | NUMBER |
| 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. Not all participants had a CGIC assessment at Week 13/Withdrawal; as such, the number analyzed is different from the full ITT Population counts. | 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 | participants | NUMBER |
| SECONDARY | Time to Onset of Sustained Improvement in the 24-hour Average Pain Intensity Score | Any time post-baseline until date of last dose of study medication (up to Week 13) | ITT Population | days | MEDIAN |
| 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 | 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. | scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Quality of Life as Assessed by the 36-Item Short Form Health Survey (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. | scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Emotional Functioning as Assessed by the Profile of Mood States-Brief Form (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. | scores on a scale | LEAST_SQUARES_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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