Trial · NCT00232141
Outcomes33
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 33
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline for Numerical Rating Scale (NRS) Pain Scores at Endpoint-LOCF (Last Observation Carried Forward) Relative to Baseline | Baseline, Week 14 | ITT population (ie, full analysis set)=all randomized participants who took at least 1 dose \& had at least 1 post-randomization efficacy assessment. The endpoint-LOCF mean value was computed from last 7 diary entries (Day 2 up to and including the day after the last dose w/n Dose-Adjustment or Maintenance phase (up to Day 99). | score on scale | LEAST_SQUARES_MEAN |
| OTHER_PRE_SPECIFIED | Change in NRS-Pain Scores From Baseline to Endpoint-BOCF (Modified Baseline Observation Carried Forward) | Baseline, Weeks 1 - 14 and Endpoint-BOCF | ITT population; n = number of participants with data for analysis reported per week per treatment group (n=pregabalin, placebo). | score on scale | LEAST_SQUARES_MEAN |
| OTHER_PRE_SPECIFIED | Responders- Decreases of at Least 50% in Mean Weekly Pain Score | Weeks 1-14 Endpoint BOCF (modified baseline observation carried forward) | ITT population; n = number of participants with data for analysis reported per week per treatment group (n=pregabalin, placebo), BOCF = modified baseline observation carried forward | participants | NUMBER |
| OTHER_PRE_SPECIFIED | Responders - Decreases of at Least 30% in Mean Weekly Pain Score | Weeks 1-14 endpoint BOCF | ITT population; n = number of participants with data for analysis reported per week per treatment group (n=pregabalin, placebo); BOCF = modified baseline observation carried forward | participants | NUMBER |
| SECONDARY | Change From Baseline for MOS (Medical Outcomes Study)-Sleep Subscales and Sleep Problem Indices | Baseline, Week 14 | ITT Population; n = number of participants with data for analysis (n=pregabalin, placebo). | score on scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline for Hospital Anxiety and Depression Scale (HADS) Subscales | Baseline, Week 14 | ITT population | score on scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline for Modified Brief Pain Inventory-Short Form (mBPI-sf) Scores | Baseline, Week 14 | ITT Population; n = number of participants with data for analysis reported (n=pregabalin, placebo). | score on scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline for NRS-Sleep Interference Scores | Baseline, Week 14 | ITT Population | score on scale | LEAST_SQUARES_MEAN |
| SECONDARY | Categorized Patient Global Impression of Change (PGIC) | Baseline, Week 14 | ITT Population | participants | NUMBER |
| SECONDARY | Patient Global Impression of Change (PGIC) Rating | Baseline, Week 14, Endpoint-LOCF | ITT Population | participants | NUMBER |
| SECONDARY | Change in Neuropathic Pain Symptom Inventory (NPSI) Subscores and Total Intensity Scores | Baseline, Week 14 | ITT Population; n = number of participants with data for analysis (n=pregabalin, placebo). | score on scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change in Quantitative Assessment of Neuropathic Pain (QANeP) | Baseline, Week 14 | ITT Population; n = number of participants with data for analysis (n=pregabalin, placebo). | score on scale | LEAST_SQUARES_MEAN |
| OTHER_PRE_SPECIFIED | Duration Adjusted Average Change From Baseline in NRS Pain Scores | Weekly: Week 1 - Week 14 | ITT Population | score on scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change in NRS-Sleep Interference Scores | Baseline, Weeks 1-14 | ITT Population; n = number of participants with data for analysis (n=pregabalin, placebo). | score on scale | LEAST_SQUARES_MEAN |
| SECONDARY | Shift in Hospital Anxiety and Depression (HADS) Subscales | Baseline, Week 14 | ITT Population | participants | NUMBER |
| SECONDARY | Change in Brief Pain Inventory-short Form (BPI-sf) Scores (The Worst Pain in the Past 24 Hours) | Baseline, Weeks 1,2,6,10,14, Endpoint - LOCF | ITT population; n = number of participants with data for analysis (n=pregabalin, placebo). | score on scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change in Brief Pain Inventory-sf Scores (The Least Pain in the Past 24 Hours) | Baseline, Weeks 1,2,6,10,14, Endpoint-LOCF | ITT population; n = number of participants with data for analysis (n=pregabalin, placebo). | score on scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change in Brief Pain Inventory-sf Scores (Average Level of Pain in the Past 24 Hours) | Baseline, Weeks 1,2,6,10,14 and Endpoint | ITT population; n = number of participants with data for analysis (n=pregabalin, placebo). | score on scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change in Brief Pain Inventory-sf Scores (How Much Pain Are You Having Right Now) | Baseline, Weeks 1,2,6,10,14 and Endpoint | ITT population; n = number of participants with data for analysis (n=pregabalin, placebo). | score on scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your General Activity) | Baseline, Weeks 1,2,6,10,14 and Endpoint | ITT population; n = number of participants with data for analysis (n=pregabalin, placebo). | score on 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.
For software
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GET https://conductscience.org/api/trials/v1/NCT00232141/outcomes