Trial · NCT00407745
Outcomes34
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 34
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Duration Adjusted Average Change (DAAC) of Mean Pain Score | Baseline, Week 16 | mITT: all randomized participants who received at least one dose of study medication except the 8 participants who were randomized before protocol amendment 2. | score on scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Weekly Mean Pain Score | Baseline, Week 16 | mITT; modified baseline observation carried forward (mBOCF) imputation: mBOCF mean pain score was defined as the baseline mean pain score for participants who discontinued double-blind treatment due to adverse event or who had no postbaseline observations and as the last observation carried forward (LOCF) mean pain score for all other participants. | score on scale | MEAN |
| SECONDARY | Number of Participants With >=30% Reduction in Weekly Mean Pain Score From Baseline | Baseline, Week 16 | mITT; LOCF: LOCF Endpoint corresponded to the last 7 days of diary data up to and including Week 16 and applied if the Week 16 assessment was missing; (N) = number of participants that can be analyzed for the endpoint. | participants | NUMBER |
| SECONDARY | Number of Participants With Categorical Scores on the Patient Global Impression of Change (PGIC) (Full Scale) | Baseline, Week 16 | mITT; LOCF; (N) = number of participants with data available for analysis | participants | NUMBER |
| SECONDARY | Change From Baseline in Weekly Mean Sleep Interference Score | Baseline, Week 16 | mITT; LOCF; (n) = number of participants with data available for analysis | score on scale | MEAN |
| SECONDARY | Change From Baseline in Weekly Mean Pain Score by Week | Baseline, Week 1 through16 | ITT population: defined as all randomized participants who took at least one dose of study medication. (This population included the 8 participants who were randomized before the protocol amendment 2). (n) = number of participants with data for analysis. | score on scale | MEAN |
| SECONDARY | Number of Participants With >=50% Reduction in Weekly Mean Pain Score From Baseline | Baseline, Week 16 | mITT; LOCF; (N) = number of participants with data available for analysis | participants | NUMBER |
| OTHER_PRE_SPECIFIED | Change From Baseline in Weekly Mean Sleep Interference Score by Week | Baseline, Week 1 through 16 | ITT; (n) = number of participants with data available for analysis | score on scale | MEAN |
| SECONDARY | Change From Baseline in Modified Brief Pain Inventory Interference Scale (10-Item) (mBPI-10) Total Score | Baseline, Week 16 | mITT; LOCF; (n) = number of participants with data available for analysis | score on scale | MEAN |
| SECONDARY | Change From Baseline in Quantitative Assessment of Neuropathic Pain (QANeP) - Static Mechanical Allodynia | Baseline, Week 16 | mITT; LOCF; (n) = number of participants with data available for analysis | score on scale | MEAN |
| SECONDARY | Change From Baseline in Quantitative Assessment of Neuropathic Pain (QANeP) - Dynamic Mechanical Allodynia | Baseline, Week 16 | mITT; LOCF; (n) = number of participants with data available for analysis | score on scale | MEAN |
| SECONDARY | Change From Baseline in Quantitative Assessment of Neuropathic Pain (QANeP)- Punctata Hyperalgesia | Baseline, Week 16 | mITT; LOCF; (n) = number of participants with data available for analysis | score on scale | MEAN |
| SECONDARY | Change From Baseline in Quantitative Assessment of Neuropathic Pain (QANeP)- Temporal Summation to Tactile Stimuli | Baseline, Week 16 | mITT; LOCF; (n) = number of participants with data available for analysis | score on scale | MEAN |
| SECONDARY | Change From Baseline in Quantitative Assessment of Neuropathic Pain (QANeP)- Cold Allodynia | Baseline, Week 16 | mITT; LOCF; (n) = number of participants with data available for analysis | score on scale | MEAN |
| SECONDARY | Change From Baseline in Quantitative Assessment of Neuropathic Pain (QANeP)- Cold Hyperalgesia Subscales | Baseline, Week 16 | mITT; LOCF; (n) = number of participants with data available for analysis | score on scale | MEAN |
| SECONDARY | Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - 12 Items Total Intensity Score | Baseline, Week 16 | mITT; LOCF; (n) = number of participants with data available for analysis | score on scale | MEAN |
| SECONDARY | Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - Burning Spontaneous Pain | Baseline, Week 16 | mITT; LOCF;(n) = number of participants with data available for analysis | score on scale | MEAN |
| SECONDARY | Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - Pressing Spontaneous Pain | Baseline, Week 16 | mITT; LOCF; (n) = number of participants with data available for analysis | score on scale | MEAN |
| SECONDARY | Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - Paroxysmal Pain | Baseline, Week 16 | mITT; LOCF; (n) = number of participants with data available for analysis | score on scale | MEAN |
| SECONDARY | Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - Evoked Pain | Baseline, Week 16 | mITT; LOCF; (n) = number of participants with data available for analysis | score on scale | 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.
For software
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT00407745/outcomes