Phase 3
N=542
Placebo-controlled Safety and Efficacy Study of Pregabalin in Subjects With Post-traumatic Peripheral Neuropathic Pain
Neuropathic Pain
Bottom Line
View on ClinicalTrials.gov: NCT01701362 ↗Enrolled (actual)
542
Serious AEs
1.7%
Results posted
Jun 2017
Primary outcome: Primary: Baseline Mean Pain Score — 6.41; 6.54 units on a scale
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
- Aug 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Baseline Mean Pain Score |
6.41; 6.54 | — |
| PRIMARY Change From Baseline to Week 15 in Weekly Mean Pain Score |
-2.12; -1.90 | 0.1823 |
| SECONDARY Patient Global Impression of Change (PGIC) at Week 15 |
52; 41; 105; 79; 61; 62 | 0.0012 sig |
| SECONDARY Change From Baseline in Overall Weekly Mean Sleep Interference Score (SIRS) |
4.97; 4.99; -0.66; -0.28; -1.15; -0.81 | 0.0119 sig |
| SECONDARY Change From Baseline in Pain Severity Index (Brief Pain Inventory-short Form [BPI-sf]) |
-2.40; -1.95 | 0.0050 sig |
| SECONDARY Change From Baseline in Pain Interference Index (BPI-sf) |
-1.72; -1.33 | 0.0168 sig |
| SECONDARY Change From Baseline to Endpoint in Quality of Life Using EuroQol (EQ-5D) Health State Profile Scores |
-0.10; -0.09; -0.08; -0.06; -0.12; -0.13 | 0.6841 |
| SECONDARY Baseline Scores in the Medical Outcomes Study Sleep Scale (MOS-SS) - Sub-domain Score. |
42.50; 43.75; 40.0; 40.0; 20.0; 20.0 | — |
| SECONDARY Mean Change From Baseline in the Medical Outcomes Study Sleep Scale (MOS-SS) - Sub-domain Score. |
-14.71; -11.24; 10.13; 8.16; -2.22; -3.27 | 0.0545 |
| SECONDARY Percentage of Participants in MOS-SS With Optimal Sleep Status. |
21.2; 18.5; 66.1; 60.8; 6.2; 13.2 | 0.7165 |
| SECONDARY Percentage of Responders to Treatment With Pregabalin Measured as Reduction in Mean Pain Score of ≥30%. |
11.92; 5.04; 27.17; 20.08; 38.89; 30.20 | 0.0028 sig |
| SECONDARY Percentage of Responders to Treatment With Pregabalin Measured as Reduction in Mean Pain Score of ≥50% |
4.62; 2.33; 11.42; 6.97; 22.62; 13.47 | 0.1633 |
Summary
This study is designed to investigate if pregabalin is effective in treating neuropathic (nerve) pain resulting from peripheral nerve trauma due to a traumatic or surgical event such as, for example, motor vehicle accident, fall, sports injury, knee or hip replacement, hernia repair, thoracotomy, mastectomy, focal/localized burns or crush injury.
Eligibility Criteria
Inclusion Criteria
- Subjects must have chronic peripheral neuropathic pain present for than 6 months after a traumatic or surgical event such as, for example, motor vehicle accident, fall, sports injury, knee or hip replacement, hernia repair, thoracotomy, mastectomy, focal/localized burns or crush injury.
- Subjects must be literate and have the ability (unaided) to understand and use the interactive voice response system (IVRS), have daily access to a telephone in order to complete the IVRS assessments each day, perform telephone visits and complete all required assessments/forms.
- Subjects must have sufficient post-traumatic neuropathic pain at screening and baseline.
Exclusion Criteria
- Subjects with neuropathic pain due to diabetic peripheral neuropathy (DPN), post herpetic neuralgia (PHN), HIV, trigeminal neuralgia (TGN), carpal tunnel syndrome (CTS) or with central neuropathic pain (for example, due to spinal cord injury) or with Complex Regional Pain Syndrome (CRPS, Type I or Type II).
- Subjects with other pain that may confound assessment or self-evaluation of the peripheral neuropathic pain.
- Subjects who have failed pregabalin treatment due to lack of efficacy with an adequate course of therapy at doses greater than or equal to 150 mg/day, who have previously participated in a pregabalin clinical trial or who have been treated with pregabalin at any time during the 6 month period prior to screening.
- Subjects with epilepsy; pernicious anemia; hematological illnesses; known HIV infection; any clinically unstable cardiovascular (including a myocardial infarction [heart attack] in the 3 months prior to screening), hematological, autoimmune, endocrine, renal, hepatic (including chronic hepatitis B, hepatitis B within the 3 months prior to screening) respiratory, or gastrointestinal disease; symptomatic peripheral vascular disease including intermittent claudication; uncontrolled diabetes mellitus; untreated hypothyroidism.
- Subjects with a diagnosis of DSM-IV TR Axis I disorder (including, for example, schizophrenia, bipolar disorder) with the exceptions of Generalized Anxiety Disorder (GAD) or major depression that is clinically stable.
- Subjects considered at risk of suicide or self-harm based on investigator judgment and/or details of a risk assessment.
- Use of prohibited medications in the absence of appropriate washout periods.
Data sourced from ClinicalTrials.gov (NCT01701362). 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.