Symptomatic Treatment Of Patients With Neuropathic Pain With LYRICA

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.691 enrolled

Overview

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.

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

Study Type

OBSERVATIONAL

Enrollment

691

Conditions

Neuropathic Pain

Interventions

PregabalinDRUG

Capsules, 150 - 600 mg/day, 2-3 times/day, 8 weeks

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: 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

Time frame: Baseline, Final Visit (Week 8 or discontinuation)

Secondary Outcomes

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.

Time frame: 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".

Time frame: 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".

Time frame: Final Visit (Week 8 or discontinuation)

Data from ClinicalTrials.gov

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