Trial · NCT01474772
Outcomes22
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 22
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Average Diabetic Peripheral Neuropathy (DPN) Pain Based on a Numeric Rating Scale (NRS) Over the Last 7 Days of Each Treatment Period (Week 6 of Each Treatment Period) | End of Period (includes both Visits 6 and 11) | All participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation were included in the Intent-to-Treat (ITT) analysis (N: 203). This was the primary analysis set. | units on a scale | LEAST_SQUARES_MEAN |
| POST_HOC | Average Weekly DPN Pain Based on a NRS (Baseline, 6 Weeks in Period 1, 2 Weeks Washout and 6 Weeks in Period 2) | Baseline, 6 weeks in Period 1, 2 weeks washout and 6 weeks in Period 2 | All participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation were included in the ITT analysis (N: 203). Numbers of participants analyzed are provided in section Measured Values in brackets (N: Pregabalin, Placebo). | units on a scale | MEAN |
| PRIMARY | DPN Pain on Walking Based on a 11-point NRS of Each Treatment Period (Week 6 of Each Treatment Period) | End of Period (includes both Visits 6 and 11) | All participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation were included in the ITT analysis (N: 203). This was the primary analysis set. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants Achieving 30% Reduction in Mean DPN Pain Score From Baseline at the End of Each Treatment Period (Week 6 of Each Treatment Period) | End of Period (includes both Visits 6 and 11) | All participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation were included in the ITT analysis (N: 203). This was the primary analysis set. Numbers of participants analyzed are provided in section Measured Values in brackets (N: Pregabalin, Placebo). | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving 50% Reduction in Mean DPN Pain Score From Baseline at the End of Each Treatment Period (Week 6 of Each Treatment Period) | End of Period (includes both Visits 6 and 11) | All participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation were included in the ITT analysis (N: 203). This was the primary analysis set. Numbers of participants analyzed are provided in section Measured Values in brackets (N: Pregabalin, Placebo). | percentage of participants | NUMBER |
| SECONDARY | Brief Pain Inventory-Short Form (BPI-sf) Score for Pain-Severity Domain at the End of Each Treatment Period (Week 6 of Each Treatment Period) | End of Period (includes both Visits 6 and 11) | All participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation were included in the ITT analysis (N: 203). This was the primary analysis set. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | BPI-sf Score for Pain-Interference Domain at the End of Each Treatment Period (Week 6 of Each Treatment Period) | End of Period (includes both Visits 6 and 11) | All participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation were included in the ITT analysis (N: 203). This was the primary analysis set. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | BPI-sf Score for Pain-Interference With Walking Ability at the End of Each Treatment Period (Week 6 of Each Treatment Period) | End of Period (includes both Visits 6 and 11) | All participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation were included in the ITT analysis (N: 203). This was the primary analysis set. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Daytime Total Activity Counts Per Day Measured by Actigraphy Over the Last 7 Days of Each Treatment Period (Week 6 of Each Treatment Period) | End of Period (includes both Visits 6 and 11) | All participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation were included in the ITT analysis (N: 203). This was the primary analysis set. | counts | LEAST_SQUARES_MEAN |
| SECONDARY | Steps Per Day Measured by Actigraphy Over the Last 7 Days of Each Treatment Period (Week 6 of Each Treatment Period) | End of Period (includes both Visits 6 and 11) | All participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation were included in the ITT analysis (N: 203). This was the primary analysis set. | steps | LEAST_SQUARES_MEAN |
| SECONDARY | Walk 12 Questionnaire Over the Last 2 Weeks of Each Treatment Period (Week 6 of Each Treatment Period) | End of Period (includes both Visits 6 and 11) | All participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation were included in the ITT analysis (N: 203). This was the primary analysis set. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Norfolk Quality of Life-Diabetic Neuropathy (Norfolk QOL-DN) Total Quality of Life (TQOL) Score Measured Over the Last 2 Weeks of Each Treatment Period (Week 6 of Each Treatment Period) | End of Period (includes both Visits 6 and 11) | All participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation were included in the ITT analysis (N: 203). This was the primary analysis set. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Norfolk QOL-DN Symptoms Domain Score Measured Over the Last 2 Weeks of Each Treatment Period (Week 6 of Each Treatment Period) | End of Period (includes both Visits 6 and 11) | All participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation were included in the ITT analysis (N: 203). This was the primary analysis set. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Norfolk QOL-DN Activities of Daily Living Domain Score Measured Over the Last 2 Weeks of Each Treatment Period (Week 6 of Each Treatment Period) | End of Period (includes both Visits 6 and 11) | All participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation were included in the ITT analysis (N: 203). This was the primary analysis set. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Norfolk QOL-DN Physical Functioning / Large Fiber Domain Score Measured Over the Last 2 Weeks of Each Treatment Period (Week 6 of Each Treatment Period) | End of Period (includes both Visits 6 and 11) | All participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation were included in the ITT analysis (N: 203). This was the primary analysis set. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Norfolk QOL-DN Small Fiber Domain Score Measured Over the Last 2 Weeks of Each Treatment Period (Week 6 of Each Treatment Period) | End of Period (includes both Visits 6 and 11) | All participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation were included in the ITT analysis (N: 203). This was the primary analysis set. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Norfolk QOL-DN Autonomic Domain Score Measured Over the Last 2 Weeks of Each Treatment Period (Week 6 of Each Treatment Period) | End of Period (includes both Visits 6 and 11) | All participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation were included in the ITT analysis (N: 203). This was the primary analysis set. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants With Patient Global Impression of Change (PGIC) Score From Baseline at the End of Period 1 (Week 6) | End of Period 1 (V6) | All participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation were included in the ITT analysis (N: 203). This was the primary analysis set. Numbers of participants analyzed are provided in section Measured Values in brackets (N: Pregabalin, Placebo). | percentage of participants | NUMBER |
| SECONDARY | Mean Sleep Interference Rating Score at the End of Each Treatment Period (Week 6 of Each Treatment Period) | End of Period (includes both Visits 6 and 11) | All participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation were included in the ITT analysis (N: 203). This was the primary analysis set. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Hospital Anxiety and Depression Scale - Anxiety (HADS-A) Total Score at the End of Each Treatment Period (Week 6 of Each Treatment Period) | End of Period (includes both Visits 6 and 11) | All participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation were included in the ITT analysis (N: 203). This was the primary analysis set. | units 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.
For software
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GET https://conductscience.org/api/trials/v1/NCT01474772/outcomes