Phase 3
N=623
Study To Evaluate Efficacy, Safety And Tolerability Of Lyrica In Patients With Painful Diabetic Peripheral Neuropathy
Diabetic Neuropathy, Painful
Bottom Line
View on ClinicalTrials.gov: NCT01332149 ↗Enrolled (actual)
623
Serious AEs
1.9%
Results posted
Jun 2015
Primary outcome: Primary: Baseline Mean Pain Score — 6.65; 6.67 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Pregabalin (Drug); Placebo matched with pregabalin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Primary completion
- Apr 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Baseline Mean Pain Score |
6.65; 6.67 | — |
| PRIMARY Change From Baseline in Mean Pain Score at Endpoint |
-2.14; -1.86 | 0.0559 |
| SECONDARY Change From Baseline in Weekly Mean Pain Score at Weeks 1 to 9 |
-0.60; -0.36; -0.97; -0.71; -1.25; -1.01 | 0.0527 |
| SECONDARY Baseline Mean Sleep Interference Score |
5.25; 5.12 | — |
| SECONDARY Change From Baseline in Mean Sleep Interference Score at Endpoint |
-1.52; -1.30 | 0.1340 |
| SECONDARY Change From Baseline in Weekly Mean Sleep Interference Score at Weeks 1 to 9 |
-0.38; -0.26; -0.66; -0.51; -0.88; -0.72 | 0.3438 |
| SECONDARY Percentage of 30 Percent (%) Responders at Endpoint |
50.3; 44.3 | 0.1309 |
| SECONDARY Change From Baseline in Short Form McGill Pain Questionnaire (SF-MPQ) Score at Weeks 1, 5, and 9 |
7.90; 8.11; -1.50; -1.34; -2.89; -2.47 | — |
| SECONDARY Baseline Pain Visual Analogue Scale (VAS) and Present Pain Intensity (PPI) Scale |
69.08; 69.06; 2.28; 2.27 | — |
| SECONDARY Change From Baseline in Pain VAS From the SF-MPQ at Endpoint |
-25.07; -21.82 | 0.0463 sig |
| SECONDARY Change From Baseline in PPI Scale From the SF-MPQ at Endpoint |
-0.80; -0.73 | 0.2748 |
| SECONDARY Baseline Medical Outcomes Study (MOS)-Sleep Scale Scores |
36.29; 35.13; 35.13; 37.59; 11.50; 10.75 | — |
| SECONDARY Change From Baseline in MOS-Sleep Scale, Sleep Disturbance Score at Endpoint |
-9.11; -7.98 | 0.4758 |
| SECONDARY Change From Baseline in MOS-Sleep Scale, Snoring Score at Endpoint |
2.78; -0.53 | 0.1363 |
| SECONDARY Change From Baseline in MOS-Sleep Scale, Awaken Short of Breath Score at Endpoint |
-2.10; -2.31 | 0.8808 |
| SECONDARY Change From Baseline in MOS-Sleep Scale, Quantity of Sleep Score at Endpoint |
0.33; 0.14 | 0.0887 |
| SECONDARY Percentage of Participants Who Had Optimal Sleep at Endpoint |
43.8; 45.0 | 0.7929 |
| SECONDARY Change From Baseline in MOS-Sleep Scale, Sleep Adequacy Score at Endpoint |
8.87; 7.82 | 0.5960 |
| SECONDARY Change From Baseline in MOS-Sleep Scale, Somnolence Score at Endpoint |
-1.22; -0.88 | 0.8216 |
| SECONDARY Change From Baseline in MOS-Sleep Scale, Sleep Problems Index Score at Endpoint |
-6.71; -5.88 | 0.4829 |
| SECONDARY Clinical Global Impression of Change (CGIC) at Endpoint |
2.58; 2.73 | 0.0431 sig |
| SECONDARY Patient Global Impression of Change (PGIC) Score at Endpoint |
2.60; 2.74 | 0.0602 |
| SECONDARY Baseline Hospital Anxiety and Depression Scale (HADS) Scores |
3.76; 3.67; 4.45; 4.35 | — |
| SECONDARY Change From Baseline in HADS Anxiety Total Score at Endpoint |
-0.48; -0.31 | 0.4172 |
| SECONDARY Change From Baseline in HADS Depression Total Score at Endpoint |
-0.57; -0.38 | 0.3724 |
Summary
Pregabalin has proven effective in previous clinical trails in other countries in relieving neuropathic pain associated with postherpetic neuralgia and painful diabetic neuropathy.
This study is being conducted according to China registration requirement to submit a reapplication with new local diabetic peripheral neuropathy study as a commitment plus the existing data to apply for Lyrica "pain associated with postherpetic neuralgia" indication after Lyrica "pain associated with postherpetic neuralgia" is approved.
Eligibility Criteria
Inclusion Criteria
- Male and female subjects aged 18 years or older
- Diagnosis of painful, distal, symmetrical, sensorimotor polyneuropathy which is due to diabetes mellitus (Type 1 or 2), and symptoms of painful diabetic neuropathy for 6 months to 5 years (inclusive).
- At the baseline and randomization visits, a score of ≥50 mm on the Visual Analogue Scale, at randomization, subjects must have completed at least 5 daily pain interference diaries, and have an average daily pain score of ≥5 over the past 7 days.
- Patient who are willing and capable to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
- Women of childbearing potential are willing to use contraception during study.
Exclusion Criteria
- Subjects with more than 30% decrease on the Pain Visual Analog Scale at randomization as compared to screening; and during the 1 week screening period, with more than one pain score <3 in pain scores.
- Subject has other kinds of neurological disorder, pain of other reason, or skin condition that could confuse the assessment.
- Subject with any other serious or unstable condition which in the opinion of the investigator might compromise participation in the study.
Data sourced from ClinicalTrials.gov (NCT01332149). 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.