Phase 3
N=203
Efficacy and Safety Study of Pregabalin in the Treatment of Pain on Walking in Patients With Diabetic Peripheral Neuropathy (DPN)
Diabetic Peripheral Neuropathy
Bottom Line
View on ClinicalTrials.gov: NCT01474772 ↗Enrolled (actual)
203
Serious AEs
2.9%
Results posted
Nov 2014
Primary outcome: 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) — 4.73; 4.96 units on a scale — p=0.0659
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Pregabalin (Drug); placebo (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Primary completion
- Jul 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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) |
4.73; 4.96 | 0.0659 |
| PRIMARY DPN Pain on Walking Based on a 11-point NRS of Each Treatment Period (Week 6 of Each Treatment Period) |
4.28; 4.41 | 0.4120 |
| 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) |
38.6; 24.5; 46.4; 47.6 | 0.0847 |
| 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) |
23.8; 13.7; 27.8; 32.1 | 0.2459 |
| 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) |
16.76; 17.56 | 0.0889 |
| SECONDARY BPI-sf Score for Pain-Interference Domain at the End of Each Treatment Period (Week 6 of Each Treatment Period) |
22.58; 23.75 | 0.1781 |
| SECONDARY BPI-sf Score for Pain-Interference With Walking Ability at the End of Each Treatment Period (Week 6 of Each Treatment Period) |
3.75; 3.93 | 0.2719 |
| 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) |
64703.14; 64139.75 | 0.8909 |
| SECONDARY Steps Per Day Measured by Actigraphy Over the Last 7 Days of Each Treatment Period (Week 6 of Each Treatment Period) |
3785.65; 3788.28 | 0.9899 |
| SECONDARY Walk 12 Questionnaire Over the Last 2 Weeks of Each Treatment Period (Week 6 of Each Treatment Period) |
35.72; 37.08 | 0.2854 |
| 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) |
29.31; 30.77 | 0.1805 |
| SECONDARY Norfolk QOL-DN Symptoms Domain Score Measured Over the Last 2 Weeks of Each Treatment Period (Week 6 of Each Treatment Period) |
7.65; 7.99 | 0.3028 |
| 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) |
2.36; 2.42 | 0.7542 |
| 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) |
15.51; 16.78 | 0.0634 |
| SECONDARY Norfolk QOL-DN Small Fiber Domain Score Measured Over the Last 2 Weeks of Each Treatment Period (Week 6 of Each Treatment Period) |
2.77; 2.53 | 0.1985 |
| SECONDARY Norfolk QOL-DN Autonomic Domain Score Measured Over the Last 2 Weeks of Each Treatment Period (Week 6 of Each Treatment Period) |
1.07; 1.08 | 0.9686 |
| SECONDARY Percentage of Participants With Patient Global Impression of Change (PGIC) Score From Baseline at the End of Period 1 (Week 6) |
11.2; 5.9; 39.8; 25.5; 30.6; 27.5 | 0.0020 sig |
| SECONDARY Mean Sleep Interference Rating Score at the End of Each Treatment Period (Week 6 of Each Treatment Period) |
3.66; 4.05 | 0.0105 sig |
| SECONDARY Hospital Anxiety and Depression Scale - Anxiety (HADS-A) Total Score at the End of Each Treatment Period (Week 6 of Each Treatment Period) |
4.65; 4.92 | 0.1178 |
| SECONDARY Hospital Anxiety and Depression Scale - Depression (HADS-D) Total Score at the End of Each Treatment Period (Week 6 of Each Treatment Period) |
3.73; 3.97 | 0.1990 |
| SECONDARY Euro QoL-5 Dimensions (EQ-5D) - Health State Profile Utility Scores at the End of Each Treatment Period (Week 6 of Each Treatment Period) |
0.649; 0.643; 0.650; 0.641 | 0.71107 |
Summary
The intent of this study is to treat subjects with painful Diabetic Peripheral Neuropathy (DPN) who also have pain on walking and to determine whether or not pregabalin demonstrates improvement relative to placebo on the following: reducing DPN pain, reducing pain on walking, and providing other benefits associated with daily activities and quality of life.
Eligibility Criteria
Inclusion Criteria
- Men or women who are at least 18 years old.
- Diagnosis of painful diabetic peripheral neuropathy.
- Pain on walking.
Exclusion Criteria
- Inability to walk 50 feet on a flat surface.
- Pain on walking due to conditions other than diabetic peripheral neuropathy.
Data sourced from ClinicalTrials.gov (NCT01474772). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.