Phase 3
N=301
Effect Of Pregabalin Treatment In Patients With Diabetic Nerve Pain Who Currently Use A Non-Steroid Anti-Inflammatory Drug (NSAID) For Another Pain
Painful Diabetic Peripheral Neuropathy
Bottom Line
View on ClinicalTrials.gov: NCT01455415 ↗Enrolled (actual)
301
Serious AEs
2.2%
Results posted
Apr 2015
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) — 4.980; 5.018 units on a scale — p=0.7174
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- pregabalin (Drug); placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Primary completion
- Nov 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) |
4.980; 5.018 | 0.7174 |
| 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) |
34.56; 31.16 | 0.3287 |
| 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) |
20.22; 15.58 | 0.0625 |
| 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) |
4.49; 4.48 | 0.9448 |
| SECONDARY BPI-sf Score for Pain-Interference Domain at the End of Each Treatment Period (Week 6 of Each Treatment Period) |
3.50; 3.59 | 0.4548 |
| SECONDARY Mean Sleep Interference Rating Score at the End of Each Treatment Period (Week 6 of Each Treatment Period) |
4.11; 4.35 | 0.0272 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) |
4.90; 4.96 | 0.7344 |
| SECONDARY HADS-D Total Score at the End of Each Treatment Period (Week 6 of Each Treatment Period) |
4.42; 4.50 | 0.6007 |
| SECONDARY Norfolk Quality of Life-Diabetic Neuropathy (Norfolk QOL-DN) Total Quality of Life (TQOL) Score at the End of Each Treatment Period (Week 6 of Each Treatment Period) |
37.22; 38.30 | 0.2987 |
| SECONDARY Norfolk QOL-DN Symptoms Domain Score at the End of Each Treatment Period (Week 6 of Each Treatment Period) |
7.51; 7.86 | 0.1769 |
| SECONDARY Norfolk QOL-DN Activities of Daily Living Domain Score at the End of Each Treatment Period (Week 6 of Each Treatment Period) |
2.82; 2.94 | 0.5119 |
| SECONDARY Norfolk QOL-DN Physical Functioning / Large Fiber Domain Score at the End of Each Treatment Period (Week 6 of Each Treatment Period) |
23.17; 23.66 | 0.4335 |
| SECONDARY Norfolk QOL-DN Small Fiber Domain Score at the End of Each Treatment Period (Week 6 of Each Treatment Period) |
2.57; 2.58 | 0.9653 |
| SECONDARY Norfolk QOL-DN Autonomic Domain Score at the End of Each Treatment Period (Week 6 of Each Treatment Period) |
1.12; 1.26 | 0.2690 |
| SECONDARY Euro QoL-5 Dimensions (EQ-5D) Mobility Domain Score at the End of Each Treatment Period (Week 6 of Each Treatment Period) |
1.65; 1.65 | 0.9951 |
| SECONDARY EQ-5D Self-Care Domain Score at the End of Each Treatment Period (Week 6 of Each Treatment Period) |
1.18; 1.18 | 0.9726 |
| SECONDARY EQ-5D Usual Activities Domain Score at the End of Each Treatment Period (Week 6 of Each Treatment Period) |
1.53; 1.51 | 0.5497 |
| SECONDARY EQ-5D Pain / Discomfort Domain Score at the End of Each Treatment Period (Week 6 of Each Treatment Period) |
2.03; 1.98 | 0.1495 |
| SECONDARY EQ-5D Anxiety / Depression Domain Score at the End of Each Treatment Period (Week 6 of Each Treatment Period) |
1.30; 1.35 | 0.1297 |
| SECONDARY EQ-5D Dolan 1997 Index Summary Score at the End of Each Treatment Period (Week 6 of Each Treatment Period) |
0.63; 0.65 | 0.4279 |
| SECONDARY EQ-5D Dolan 2002 Index Summary Score at the End of Each Treatment Period (Week 6 of Each Treatment Period) |
0.63; 0.64 | 0.5505 |
| SECONDARY Patient Global Impression of Change (PGIC) Score at the End of Period 1 (Week 6) - Original Scores |
8.1; 4.9; 27.7; 19.6; 39.2; 39.2 | 0.0604 |
| SECONDARY PGIC Score at the End of Period 1 (Week 6) - Categorized Scores |
35.8; 24.5; 75.0; 63.6; 14.9; 23.1 | 0.1511 |
Summary
This study is to test the effectiveness of pregabalin in treating nerve pain caused by diabetes. The suitable subjects will be patients who also use an non-steroid anti-inflammatory drug for another pain which is not related to the diabetic nerve pain.
Eligibility Criteria
Inclusion Criteria
- Type 1 or 2 diabetes with painful neuropathy
- Currently treated with one NSAID (including COX 2 inhibitors) for a co morbid pain condition with a regular dose
- Meet pre-defined level of pain severity at entrance
Exclusion Criteria
- History of failed pregabalin treatment due to lack of efficacy at therapeutic dose
- Participated in a previous or ongoing pregabalin clinical trial
- Neurologic disorders unrelated to diabetic neuropathy that may confound the assessment of distal neuropathic pain
Data sourced from ClinicalTrials.gov (NCT01455415). 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.