Phase 3
N=665
Study Of Pregabalin (Lyrica) In Patients With Painful Diabetic Peripheral Neuropathy
Diabetic Neuropathy, Painful
Bottom Line
View on ClinicalTrials.gov: NCT01057693 ↗Enrolled (actual)
665
Serious AEs
3.5%
Results posted
Feb 2013
Primary outcome: Primary: Change From Single-Blind Baseline in Mean Pain Score at Week 19 During Double-Blind Phase — 6.8; 6.7; -3.9; -3.5 units on a scale — p=0.1221
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- pregabalin (Lyrica) (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
- Jan 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Single-Blind Baseline in Mean Pain Score at Week 19 During Double-Blind Phase |
6.8; 6.7; -3.9; -3.5 | 0.1221 |
| SECONDARY Time to Loss of Pain Response (Double-Blind Phase) |
NA; NA | — |
| SECONDARY Change From Single-Blind Baseline in Mean Pain Score at Week 6 During Single-Blind Phase |
6.7; -2.2 | — |
| SECONDARY Weekly Mean Pain Scores (Single-Blind Phase) |
6.0; 5.4; 4.9; 4.6; 4.5; 4.3 | — |
| SECONDARY Weekly Mean Pain Scores (Double-Blind Phase) |
3.1; 3.0; 3.2; 3.3; 3.2; 3.6 | — |
| SECONDARY Percentage of Participants With At Least 30 Percent and 50 Percent Reduction in Mean Pain Score (Single-Blind Phase) |
49.92; 27.22 | — |
| SECONDARY Percentage of Participants With At Least 30 Percent and 50 Percent Reduction in Mean Pain Score (Double-Blind Phase) |
82.99; 79.19; 62.59; 55.03 | — |
| SECONDARY Patient Global Impression of Change (PGIC) (Single-Blind Phase) |
93; 221; 194; 65; 29; 15 | — |
| SECONDARY Patient Global Impression of Change (PGIC) (Double-Blind Phase) |
23; 23; 50; 46; 27; 28 | — |
| SECONDARY Medical Outcomes Study -Sleep Scale (MOS-SS) (Single-Blind Phase) |
53.6; 44.7; 18.9; 5.9; 39.2; 42.6 | — |
| SECONDARY Medical Outcomes Study -Sleep Scale (MOS-SS) (Double-Blind Phase) |
26.6; 30.9; 41.9; 35.4; 12.3; 12.2 | — |
| SECONDARY Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study-Sleep Scale (MOS-SS) (Single-Blind Phase) |
180; 266 | — |
| SECONDARY Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study-Sleep Scale (MOS-SS) (Double-Blind Phase) |
67; 60 | — |
| SECONDARY Weekly Mean Sleep Interference Score (Single-Blind Phase) |
5.9; 5.1; 4.5; 4.1; 3.8; 3.7 | — |
| SECONDARY Weekly Mean Sleep Interference Score (Double-Blind Phase) |
2.5; 2.3; 2.6; 2.7; 2.6; 3.0 | — |
| SECONDARY Endpoint Mean Sleep Interference Score (Single-Blind Phase) |
3.8 | — |
| SECONDARY Endpoint Mean Sleep Interference Score (Double-Blind Phase) |
2.4; 2.4 | — |
| SECONDARY Quality of Life Questionnaire- Diabetic Neuropathy (QOL-DN) (Single-Blind Phase) |
42.6; 23.9; 3.2; 10.8; 3.4; 1.3 | — |
| SECONDARY Quality of Life Questionnaire- Diabetic Neuropathy (QOL-DN) (Double-Blind Phase) |
21.9; 24.1; 11.4; 12.9; 1.8; 1.8 | — |
| SECONDARY Pain Visual Analog Scale (VAS) (Single-Blind Phase) |
68.1; 39.8 | — |
| SECONDARY Pain Visual Analog Scale (VAS) (Double-Blind Phase) |
25.3; 30.1 | — |
| SECONDARY Brief Pain Inventory-Short Form (BPI-sf) (Single-Blind Phase) |
6.1; 5.2; 3.9; 3.1 | — |
| SECONDARY Brief Pain Inventory-Short Form (BPI-sf) (Double-Blind Phase) |
2.6; 3.0; 2.0; 2.4 | — |
| SECONDARY Hospital Anxiety and Depression Scale (HADS) (Single-Blind Phase) |
5.8; 5.3; 4.6; 4.0 | — |
| SECONDARY Hospital Anxiety and Depression Scale (HADS) (Double-Blind Phase) |
3.8; 4.3; 3.3; 3.5 | — |
| SECONDARY Patient Global Evaluation of Study Medication (GESM) (Single-Blind Phase) |
241; 181; 66; 71; 22; 21 | — |
| SECONDARY Patient Global Evaluation of Study Medication (GESM) (Double-Blind Phase) |
80; 64; 35; 36; 9; 14 | — |
Summary
Patients will be switched from their current medication for painful diabetic peripheral neuropathy to evaluate the safety and efficacy of pregabalin as compared to placebo. All patients will receive pregabalin, and half of patients will receive placebo at some point during the study.
Eligibility Criteria
Inclusion Criteria
- Patients must have painful diabetic peripheral neuropathy and be receiving treatment for this condition.
Exclusion Criteria
- Patients with other pain conditions cannot participate.
Data sourced from ClinicalTrials.gov (NCT01057693). 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.