N/A
Completed N=691
Symptomatic Treatment Of Patients With Neuropathic Pain With LYRICA
Source: ClinicalTrials.gov NCT00843284 ↗Enrolled (actual)
691
Serious AEs
—
Results posted
Apr 2009
Primary outcomePrimary: Daily Average Pain Scores — 7.61; 3.46; -4.16 scores on scale — p=<0.0001
Summary
A Non-Interventional, Post-Marketing Surveillance (NI-PMS) study whose objectives were to assess the impact of pregabalin on subjects' pain, quality of sleep, and their general wellbeing, as well as the tolerance and safety of pregabalin in subjects with neuropathic pain.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Daily Average Pain Scores |
7.61; 3.46; -4.16 | <0.0001 sig |
| PRIMARY Pain Related Sleep Interference |
6.28; 2.27; -4.02 | <0.0001 sig |
| SECONDARY Anxiety and Depression Symptoms |
8; 14; 57; 199; 186; 183 | — |
| SECONDARY Clinician Global Improvement of Change (CGIC) at Final Visit (Week 8 or Discontinuation) |
0; 160; 292; 171; 39; 1 | — |
| SECONDARY Patient Global Improvement of Change (PGIC) at Final Visit (Week 8 or Discontinuation) |
0; 175; 245; 193; 44; 7 | — |
Eligibility Criteria
Inclusion Criteria
- Clinical diagnosis of neuropathic pain and inclusion according to the current Summary of Product Characteristics.
Exclusion Criteria
- The patients were excluded according to the current Summary of Product Characteristics.
Data sourced from ClinicalTrials.gov (NCT00843284). 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. Informational only — not medical advice.