Symptomatic Treatment Of Patients With Neuropathic Pain With LYRICA (NI-PMS)

January 21, 2021 updated by: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Observational

Enrollment (Actual)

691

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with neuropathic pain

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with neuropathic pain
Drug: Pregabalin
Capsules, 150 - 600 mg/day, 2-3 times/day, 8 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Daily Average Pain Scores
Time Frame: 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.
Baseline, Final Visit (Week 8 or discontinuation)
Pain Related Sleep Interference
Time Frame: 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
Baseline, Final Visit (Week 8 or discontinuation)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anxiety and Depression Symptoms
Time Frame: 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.
Baseline, Final Visit (Week 8 or discontinuation)
Clinician Global Improvement of Change (CGIC) at Final Visit (Week 8 or Discontinuation)
Time Frame: 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)
Time Frame: 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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2006

Primary Completion (Actual)

March 1, 2008

Study Completion (Actual)

March 1, 2008

Study Registration Dates

First Submitted

February 12, 2009

First Submitted That Met QC Criteria

February 12, 2009

First Posted (Estimate)

February 13, 2009

Study Record Updates

Last Update Posted (Actual)

February 10, 2021

Last Update Submitted That Met QC Criteria

January 21, 2021

Last Verified

October 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A0081139
  • ATLAS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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