Phase 3
N=240
Pregabalin Peripheral Neuropathic Pain Study
Diabetic Neuropathies · Neuralgia
Bottom Line
View on ClinicalTrials.gov: NCT00141219 ↗Enrolled (actual)
240
Serious AEs
1.3%
Results posted
Mar 2009
Primary outcome: Primary: Daily Pain Rating Scale (DPRS)- Mean Pain Score (ITT Population) — 4.63; 5.13 score on scale — p=0.049
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
- Dec 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Daily Pain Rating Scale (DPRS)- Mean Pain Score (ITT Population) |
4.63; 5.13 | 0.049 sig |
| SECONDARY Daily Pain Rating Scale (DPRS)- Number of 30% Responders (With Respect to Pain Scores) |
68; 27; 93; 50 | 0.289 |
| SECONDARY Daily Pain Rating Scale (DPRS)- Number of 50% Responders (With Respect to Pain Scores) |
42; 11; 119; 66 | 0.041 sig |
| SECONDARY Daily Pain Rating Scale (DPRS)- Weekly Mean Pain Score |
4.91; 5.29; 5.80; 6.18; 5.30; 5.61 | 0.042 sig |
| SECONDARY Duration Adjusted Average Change (DAAC) of (Adjusted) Mean Pain Score |
-1.27; -0.89 | 0.044 sig |
| SECONDARY Mean Sleep Interference Score Based on Daily Sleep Interference Scale (DSIS). |
3.26; 3.91 | 0.018 sig |
| SECONDARY Mean Sleep Score as Computed by DSIS. |
3.46; 3.97; 4.18; 4.56; 3.74; 4.24 | 0.024 sig |
| SECONDARY Medical Outcome Study (MOS) Sleep Disturbance |
28.96; 34.58 | 0.034 sig |
| SECONDARY Medical Outcome Study (MOS) Snoring Score |
34.21; 29.16 | 0.128 |
| SECONDARY Medical Outcome Study (MOS) Awaken Short of Breath or Headache |
6.90; 9.98 | 0.103 |
| SECONDARY Medical Outcome Study (MOS) Sleep Quantity |
6.46; 6.02 | 0.018 sig |
| SECONDARY Medical Outcome Study (MOS) Optimal Sleep: Number of Participants With Optimal Sleep |
85; 44; 73; 31 | .504 |
| SECONDARY Medical Outcome Study (MOS) Sleep Adequacy |
48.81; 46.65 | 0.571 |
| SECONDARY Medical Outcome Study (MOS) Somnolence |
34.02; 29.31 | 0.046 sig |
| SECONDARY Medical Outcome Study (MOS) Overall Sleep Problems Index |
32.27; 34.40 | 0.300 |
| SECONDARY Euro Quality of Life (QOL) (EQ-5D) Utility Score |
0.651; 0.626 | 0.429 |
| SECONDARY Euro Quality of Life (EQ-5D) Visual Analog Scale (VAS) |
61.53; 58.03 | 0.142 |
| SECONDARY Hospital Anxiety and Depression Scale- Anxiety (HADS-A) Score |
6.01; 6.86 | 0.038 sig |
| SECONDARY Hospital Anxiety and Depression Scale- Depression (HADS-D) Score |
7.54; 7.73 | 0.664 |
| SECONDARY Patient Global Impression of Change (PGIC) |
118; 54; 29; 12; 11; 9 | 0.473 |
| SECONDARY Clinical Global Impression of Change (CGIC) |
117; 51; 37; 16; 6; 10 | 0.119 |
| SECONDARY Duration Adjusted Average Change (DAAC) of (Unadjusted) Mean Pain Score |
-1.24; -0.87 | — |
Summary
To evaluate the efficacy of pregabalin, using a flexible, optimized dose schedule with dose adjustment based on Daily Pain Rating Scale (DPRS), compared to placebo in subjects with peripheral neuropathic pain.
Eligibility Criteria
Inclusion Criteria
- Diagnosis of peripheral neuropathic pain syndrome, including diabetic peripheral neuropathy (DPN), postherpetic neuralgia (PHN), or post-traumatic neuropathic pain (including post-surgical), confirmed by a qualified pain specialist.
- Subjects must have completed at least 4 daily pain diaries during the 7 days prior to Visit 2 and have an average pain score of ≥4 over the 7 days prior to Visit 2 (randomization).
Exclusion Criteria
- Neurologic disorders unrelated to DPN, PHN, or post-traumatic neuropathic pain (including post-surgical), that may confuse or confound the assessment of neuropathic pain.
- Presence of any severe pain associated with conditions other than DPN, PHN, or post-traumatic neuropathic pain (including post-surgical) that may confound the assessment or self evaluation of the pain due to DPN, PHN, or post-traumatic neuropathic pain (including post-surgical).
- Creatinine clearance < 30 mL/min (estimated from serum creatinine, body weight, age, and sex using the Cockcroft and Gault equation in Appendix E). Maximum dose for subjects with creatinine clearance of 30 to 60 mL/min is 300 mg/day
Data sourced from ClinicalTrials.gov (NCT00141219). 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.