Symptomatic Treatment Of Patients With Neuropathic Pain With LYRICA

Study Overview
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Brief Summary
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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.

Detailed Description
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A non-interventional study of patients diagnosed with neuropathic pain administered pregabalin and followed up for 8 weeks

Official Title
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Assessing the Treatment of Patients With Neuropathic Pain Using LYRICA; A Non Interventional Post-marketing Study (NI-PMS)

Conditions
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Neuropathic Pain

Intervention / Treatment
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* Drug: Pregabalin


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with neuropathic pain<br> | Drug: Pregabalin<br>* Capsules, 150 - 600 mg/day, 2-3 times/day, 8 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Daily Average Pain Scores | Change is observed value at final visit (Week 8 or discontinuation) minus baseline value. Daily average pain score is measured using a 10-point Likert scale where 0 = no pain to 10 = pain as bad as you can imagine. | Baseline, Final Visit (Week 8 or discontinuation) | 
| Pain Related Sleep Interference | Change is observed value at final visit (Week 8 or discontinuation) minus baseline value. Pain related sleep interference is measured by a 10-point Likert scale where 0 = does not interfere with sleep, and 10 = completely interferes with sleep | Baseline, Final Visit (Week 8 or discontinuation) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety and Depression Symptoms | The presence of anxiety and depression symptoms were measured, based on how often the subject felt a certain emotion over the past week. Q1:Have you felt calm and relaxed? Q2: Have you felt full of energy? Q3: Have you felt discouraged and sad? Final Visit = Week 8 or time of discontinuation. | Baseline, Final Visit (Week 8 or discontinuation) | 
| Clinician Global Improvement of Change (CGIC) at Final Visit (Week 8 or Discontinuation) | Clinician Global Improvement of Change (CGIC) indicates the change of the severity of the condition from baseline, graded from very much improved to very much worse. | Final Visit (Week 8 or discontinuation) | 
| Patient Global Improvement of Change (PGIC) at Final Visit (Week 8 or Discontinuation) | Patient Global Improvement of Change (PGIC) indicates the change of severity of conditions from baseline, graded from very much improved to very much worse. | Final Visit (Week 8 or discontinuation) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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neuropathic, pain, pregabalin, Lyrica