Phase 3
N=314
Randomized, Double-Blind, Multicenter, Placebo-Controlled Study Of Pregabalin For Pain Associated With Diabetic Peripheral Neuropathy
Diabetic Neuropathy, Painful
Bottom Line
View on ClinicalTrials.gov: NCT00553475 ↗Enrolled (actual)
314
Serious AEs
1.9%
Results posted
Jun 2010
Primary outcome: Primary: Change From Baseline to Study Endpoint in Mean Weekly Pain Scores — -1.20; -1.82; -1.94 score on scale — p=0.0075
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- placebo (Drug); pregabalin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Primary completion
- Mar 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to Study Endpoint in Mean Weekly Pain Scores |
-1.20; -1.82; -1.94 | 0.0075 sig |
| PRIMARY Change From Baseline to Study Endpoint in Mean Weekly Pain Scores by Groups of Subjects With Expected Similar Plasma Concentrations |
-1.27; -1.93; -1.90 | 0.0058 sig |
| PRIMARY Number of Responders |
29; 39; 16 | 0.153 |
| PRIMARY Change From Baseline at Week 1 in Mean Weekly Pain Scores |
-0.39; -0.82; -1.14 | 0.0287 sig |
| PRIMARY Change From Baseline at Week 2 in Mean Weekly Pain Scores |
-0.57; -1.17; -1.80 | 0.0021 sig |
| PRIMARY Change From Baseline at Week 3 in Mean Weekly Pain Scores |
-0.80; -1.40; -1.93 | 0.0026 sig |
| PRIMARY Change From Baseline at Week 4 in Mean Weekly Pain Scores |
-0.89; -1.53; -2.00 | 0.0012 sig |
| PRIMARY Change From Baseline at Week 5 in Mean Weekly Pain Scores |
-0.91; -1.57; -2.07 | 0.0011 sig |
| PRIMARY Change From Baseline at Week 6 in Mean Weekly Pain Scores |
-0.94; -1.72; -2.06 | <0.0001 sig |
| PRIMARY Change From Baseline at Week 7 in Mean Weekly Pain Scores |
-1.04; -1.76; -2.13 | 0.0003 sig |
| PRIMARY Change From Baseline at Week 8 in Mean Weekly Pain Scores |
-1.18; -1.85; -2.12 | 0.0008 sig |
| PRIMARY Change From Baseline at Week 9 in Mean Weekly Pain Scores |
-1.20; -1.93; -2.06 | 0.0003 sig |
| PRIMARY Change From Baseline at Week 10 in Mean Weekly Pain Scores |
-1.23; -1.93; -2.10 | 0.0005 sig |
| PRIMARY Change From Baseline at Week 11 in Mean Weekly Pain Scores |
-1.32; -1.95; -2.09 | 0.0023 sig |
| PRIMARY Change From Baseline at Week 12 in Mean Weekly Pain Scores |
-1.36; -2.01; -2.13 | 0.0016 sig |
| PRIMARY Change From Baseline at Week 13 in Mean Weekly Pain Scores |
-1.38; -2.04; -2.12 | 0.0013 sig |
| SECONDARY Change From Baseline in Short Form 36-Item (SF-36) Health Survey: Physical Functioning |
2.70; 2.43; 3.86 | 0.8731 |
| SECONDARY Change From Baseline in Short Form 36-Item (SF-36) Health Survey: Role Limitations-Physical |
4.38; 2.28; 3.97 | 0.4398 |
| SECONDARY Change From Baseline in Short Form 36-Item (SF-36) Health Survey: Bodily Pain |
10.34; 11.84; 12.89 | 0.4873 |
| SECONDARY Change From Baseline in Short Form 36-Item (SF-36) Health Survey: General Health Perception |
2.31; 3.29; 4.40 | 0.5372 |
| SECONDARY Change From Baseline in Short Form 36-Item (SF-36) Health Survey: Social Functioning |
3.00; 8.06; 11.16 | 0.0544 |
| SECONDARY Change From Baseline in Short Form 36-Item (SF-36) Health Survey: Role Limitations-Emotional |
4.13; 5.05; 6.35 | 0.7394 |
| SECONDARY Change From Baseline in Short Form 36-Item (SF-36) Health Survey: Vitality |
5.28; 4.20; 12.87 | 0.6118 |
| SECONDARY Change From Baseline in Short Form 36-Item (SF-36) Health Survey: Mental Health |
3.84; 5.33; 7.81 | 0.4602 |
| SECONDARY Change From Baseline in Mean Sleep Interference Scores |
-0.74; -1.59; -1.36 | <0.0001 sig |
| SECONDARY Change From Baseline in Short-Form McGill Pain Questionnaire: Sensory Scores |
-2.82; -4.60; -4.95 | 0.0013 sig |
| SECONDARY Change From Baseline in Short-Form McGill Pain Questionnaire: Affective Scores |
-0.83; -1.43; -1.39 | 0.0068 sig |
| SECONDARY Change From Baseline in Short-Form McGill Pain Questionnaire: Total Scores |
-3.68; -6.03; -6.36 | 0.0013 sig |
| SECONDARY Change From Baseline in Short-Form McGill Pain Questionnaire: Visual Analogue Scale Scores |
-16.92; -24.19; -24.41 | 0.0056 sig |
| SECONDARY Change From Baseline in Short-Form McGill Pain Questionnaire: Present Pain Intensity Scores |
-0.59; -0.80; -0.96 | 0.0365 sig |
| SECONDARY Change From Baseline in Medical Outcomes Study (MOS) - Sleep Scale: Sleep Disturbance |
-9.03; -15.40; -12.81 | 0.0019 sig |
| SECONDARY Change From Baseline in Medical Outcomes Study (MOS) - Sleep Scale: Snoring |
-6.00; -5.96; -1.56 | 0.9905 |
| SECONDARY Change From Baseline in Medical Outcomes Study (MOS) - Sleep Scale: Sleep Shortness of Breath or Headache |
-1.63; -3.02; -4.47 | 0.4538 |
| SECONDARY Change From Baseline in Medical Outcomes Study (MOS) - Sleep Scale: Quantity of Sleep |
0.37; 0.69; 0.54 | 0.0177 sig |
| SECONDARY Change From Baseline in Medical Outcomes Study (MOS) - Sleep Scale: Sleep Adequacy |
12.08; 17.69; 21.73 | 0.0511 |
| SECONDARY Change From Baseline in Medical Outcomes Study (MOS) - Sleep Scale: Somnolence |
-2.96; 0.83; 4.83 | 0.1123 |
| SECONDARY Change From Baseline in Medical Outcomes Study (MOS) - Sleep Scale: Overall Sleep Problems Index |
-7.91; -11.45; -9.73 | 0.0269 sig |
| SECONDARY Clinical Global Impression of Change |
3.3; 2.9; 2.7 | 0.0148 sig |
| SECONDARY Patient Global Impression of Change |
3.4; 3.2; 2.8 | 0.0818 |
Summary
To evaluate the efficacy and safety of pregabalin at 300 mg/day and 600 mg/day (BID) in patients with painful diabetic peripheral neuropathy.
Eligibility Criteria
Inclusion Criteria
- Visual Analogue Scale (VAS) of pain is higher than 40 mm.
- Diagnosis of type 1 or 2 diabetes mellitus for at least 1 year
Exclusion Criteria
- Malignancy within the past 2 years.
- Neurologic disorders unrelated to diabetic neuropathy that may confuse the assessment of neuropathy pain
Data sourced from ClinicalTrials.gov (NCT00553475). 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.