Symptomatic Treatment Of Patients With Neuropathic Pain With LYRICA

Completed

• Conditions: Neuropathic Pain
• Interventions: Drug: Pregabalin

• Registration Number: NCT00843284
• Lead Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Brief 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.

Detailed Description

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

Study Timeline

• Study Start: 2006-09
• Primary Completion: 2008-03
• Study Completion: 2008-03
• Study First Submitted: 2009-02-12
• Study First Submitted QC: 2009-02-12
• Study First Posted: 2009-02-13
• Results First Submitted: 2009-03-11
• Results First Submitted QC: 2009-03-12
• Results First Posted: 2009-04-16
• Status Verified: 2009-10
• Last Update Submitted: 2021-01-21
• Last Update Posted: 2021-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 691

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with neuropathic pain	Pregabalin	-

Primary Outcome Measures

Name	Time	Method
Daily Average Pain Scores	Baseline, Final Visit (Week 8 or discontinuation)	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.
Pain Related Sleep Interference	Baseline, Final Visit (Week 8 or discontinuation)	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

Secondary Outcome Measures

Name	Time	Method
Anxiety and Depression Symptoms	Baseline, Final Visit (Week 8 or discontinuation)	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.
Patient Global Improvement of Change (PGIC) at Final Visit (Week 8 or Discontinuation)	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".
Clinician Global Improvement of Change (CGIC) at Final Visit (Week 8 or Discontinuation)	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".