Skip to main content
OpenTrials
Completed

NCT Number: NCT00892008

A Post Marketing Surveillance Study On Pregabalin (Lyrica) On Efficacy, Safety And Tolerability Of Pregabalin

This study is being conducted as a regulatory requirement post initial marketing authorization. This is primarily a safety study. This was an open label study and patients were enrolled once the decision to prescribe the medication was made by the Investigator.

Completed

Looking for future studies?

Notify Me

Key information

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male or female, 18 years old and above diagnosed with neuropathic pain.

Exclusion criteria

  • Patients that are pregnant and lactating; and patients with known hypersensitivity to pregabalin or its related components.

Treatment and study plan

Pregabalin

Drug

Pregabalin 75-150 mg BID for at least 2 weeks.

Other names: Lyrica

Primary outcomes

  1. Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4)

    Time frame: Baseline through Final Visit (Week 4)

    Number and severity of adverse events, including serious adverse events. If the same subject had more than one occurance in the same preferred term event category, only the most severe occurrence was taken.

  2. Discontinuations Due to Adverse Events

    Time frame: Baseline, Second Visit (Week ≥ 2), Final Visit (Week 4)

    Discontinuations due to adverse events by MedDRA system organ class and preferred term.

Secondary outcomes

  1. Change From Baseline in Visual Analogue Scale (VAS) Score

    Time frame: Baseline, Second Visit (Week ≥ 2), Final Visit (Week 4)

    Change from Baseline in 10 cm VAS pain score; 10-point pain intensity ordinal rating system: 0 = no pain, 1-3 = mild pain, 4-6 = moderate pain, 7-9 = severe pain, 10 = worst possible pain. Change = scores at second visit and final visit minus score at Baseline.

  2. VAS Pain Score at Baseline (BL) and Second Visit

    Time frame: Baseline, Second Visit (Week ≥ 2)

    VAS Pain Score: 10 cm (10-point) pain intensity ordinal rating system: 0 = no pain, 1-3 = mild pain, 4-6 = moderate pain, 7-9 = severe pain, 10 = worst possible pain. Shift table shows the number of subjects with each pain intensity rating at the Second Visit by the number of subjects with each pain intensity rating at Baseline. Abbreviations: mod = moderate, sev = severe, wrst = worst, poss = possible, pn = pain, vst = visit .

  3. VAS Pain Score at Baseline and Final Visit

    Time frame: Baseline, Final Visit (Week 4)

    VAS Pain Score 10 cm (10-point) pain intensity ordinal rating system: 0 = no pain, 1-3 = mild pain, 4-6 = moderate pain, 7-9 = severe pain, 10 = worst possible pain. Shift table shows the number of subjects with each pain intensity rating at the Final Visit by the number of subjects with each pain intensity rating at Baseline. Abbreviations: mod = moderate, sev = severe, wrst = worst, poss = possible, pn = pain, vst = visit.

  4. Physician's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits

    Time frame: Second Visit (Week ≥ 2), Final Visit (Week 4)

    Physician's Clinical Global Impression of treatment satisfaction. Treatment satisfaction item of the CGI has a scale of five discrete score points: excellent, very good, good, fair and poor. Shift table shows the number of subjects with each score point rating at the Final Visit by the number of subjects with each score point rating at the Second Visit.

  5. Patient's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits

    Time frame: Second Visit (Week ≥ 2), Final Visit (Week 4)

    Patient's Clinical Global Impression of treatment satisfaction. Treatment satisfaction item of CGI has a scale of five discrete points: excellent, very good, good, fair and poor. Shift table shows the number of subjects with each score point rating at the Final Visit by the number of subjects with each score point rating at the Second Visit.

  6. Physician's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit

    Time frame: Second Visit (Week ≥ 2), Final Visit (Week 4)

    Physician's Clinical Global Impression of efficacy. Efficacy item of the CGI has a scale of five discrete points: excellent, very good, good, fair and poor. Shift table shows the number of subjects with each score point rating at the Final Visit by the number of subjects with each score point rating at the Second Visit.

  7. Patient's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit

    Time frame: Second Visit (Week ≥ 2), Final Visit (Week 4)

    Patient's Clinical Global Impression of efficacy. Efficacy item of CGI has a scale of five discrete points: excellent, very good, good, fair and poor. Shift table shows the number of subjects with each score point rating at the Final Visit by the number of subjects with each score point rating at the Second Visit.

  8. Physician's Clinical Global Impression (CGI) on Tolerability at Second and Final Viist

    Time frame: Second Visit (Week ≥ 2), Final Visit (Week 4)

    Physician's Clinical Global Impression of tolerability. Tolerability item of CGI has a scale of five discrete points: excellent, very good, good, fair and poor. Shift table shows the number of subjects with each score point rating at the Final Visit by the number of subjects with each score point rating at the Second Visit.

  9. Patient's Clinical Global Impression (CGI) of Tolerability at Second and Final Visit

    Time frame: Second Visit (Week ≥ 2), Final Visit (Week 4)

    Patient's Clinical Global Impression of tolerability. The tolerability item of CGI has a scale of five discrete points: excellent, very good, good, fair and poor. Shift table shows the number of subjects with each score point rating at the Final Visit by the number of subjects with each score point rating at the Second Visit. Abbreviation: vst = visit.

Sponsors and collaborators

Lead sponsor

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

Industry

Registry information

Official study title

Pregabalin (Lyrica) Action In Neuropathic Pain Syndrome (PAINS): A Post Marketing Surveillance Study On Efficacy, Safety And Tolerability Of Pregabalin

Acronym: PAINS

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
May 1, 2009
Registry last updated
Jan 25, 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.

Published trials that share one or more normalized conditions with this study.