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Completed

NCT Number: NCT00843284

Symptomatic Treatment Of Patients With Neuropathic Pain With LYRICA

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.

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Key information

Conditions

Neuropathic Pain Nervous System Diseases Neuralgia Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pregabalin

Drug

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

Primary outcomes

  1. 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.

  2. 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

Secondary outcomes

  1. 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.

  2. 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".

  3. 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".

Sponsors and collaborators

Lead sponsor

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

Industry

Registry information

Official study title

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

Acronym: NI-PMS

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Feb 13, 2009
Registry last updated
Feb 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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