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Completed

NCT Number: NCT01220180

Lyrica (Pregabalin) Korean Post Marketing Surveillance Study

This study collects post-marketing safety and efficacy surveillance data in real world clinical use of pregabalin for its approved indications in Korea.

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Key information

Conditions

Epilepsy Brain Diseases Central Nervous System Diseases Fibromyalgia Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuralgia Neurologic Manifestations Neuromuscular Diseases Neuropathic Pain Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Post-market Surveillance Rheumatic Diseases Signs and Symptoms

Sex eligibility

All sexes

Study type

Observational

About this study

continuous patients with target disorders in collaborating institutions

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Any patient treated with pregabalin for an approved indication by Korean Food and Drug Administration

Exclusion criteria

  • Non-consenting
  • Hypersensitivity to the active substance or to any of the excipients
  • galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.

Treatment and study plan

pregabalin (Lyrica)

Drug

Pregabalin treatment can be started with a dose of 150 mg per day. Based on individual subject response and tolerability, the dosage may be increased to 300 mg per day after 1 week. The maximum dosage of 600 mg per day may be achieved after an additional week.

Primary outcomes

  1. Percentage of Participants Achieving 28 Days Seizure Free Period in Intent-to Treat (ITT) Population

    Time frame: Baseline through Week 12

    Participants were regarded as seizure-free if no seizures (partial or other) were reported for the participant during the period of 28 days in the study.

  2. Percentage of Participants Achieving 28 Days Seizure Free Period in Per Protocol (PP) Population

    Time frame: Baseline through Week 12

    Participants were regarded as seizure-free if no seizures (partial or other) were reported for the participant during the period of 28 days in the study.

  3. Percentage of Participants With Improvement in Seizure Frequency in ITT Population

    Time frame: Baseline through Week 12

    Percentage of participants with improvement in seizure frequency of greater than or equal to 75%; greater than or equal to 50% to 74%; 0% to 49% were considered.

  4. Percentage of Participants With Improvement in Seizure Frequency in PP Population

    Time frame: Baseline through Week 12

    Percentage of participants with improvement in seizure frequency of greater than or equal to 75%; greater than or equal to 50% to 74%; 0% to 49% were considered.

  5. Change From Baseline in Daily Pain Score for NeP in ITT Population at Week 6

    Time frame: Baseline and Week 6

    Daily Pain Rating Score (DPRS): participant rated 11-point Likert scale ranging from 0 (no pain) to 10 (worst possible pain) during past 24-hour period. Higher score indicates greater level of pain.

  6. Change From Baseline in Daily Pain Score for NeP in PP Population at Week 6

    Time frame: Baseline and Week 6

    DPRS: participant rated 11-point Likert scale ranging from 0 (no pain) to 10 (worst possible pain) during past 24-hour period. Higher score indicates greater level of pain.

  7. Change From Baseline in Daily Pain Score for Fibromyalgia in ITT Population at Week 6

    Time frame: Baseline and Week 6

    DPRS: participant rated 11-point Likert scale ranging from 0 (no pain) to 10 (worst possible pain) during past 24-hour period. Higher score indicates greater level of pain.

  8. Change From Baseline in Daily Pain Score for Fibromyalgia in PP Population at Week 6

    Time frame: Baseline and Week 6

    DPRS: participant rated 11-point Likert scale ranging from 0 (no pain) to 10 (worst possible pain) during past 24-hour period. Higher score indicates greater level of pain.

Secondary outcomes

  1. Change From Baseline in Sleep Interference Score for NeP in ITT Population at Week 6

    Time frame: Baseline and Week 6

    Daily Sleep Interference Score (DSIS): participant rated 11-point Likert scale ranging from 0 (pain does not interfere with sleep) to 10 (pain completely interferes with sleep) during past 24-hour period. Higher score indicates a greater level of sleep disturbance. Self-assessment performed daily on awakening prior to taking study medication.

  2. Change From Baseline in Sleep Interference Score for NeP in PP Population at Week 6

    Time frame: Baseline and Week 6

    DSIS: participant rated 11-point Likert scale ranging from 0 (pain does not interfere with sleep) to 10 (pain completely interferes with sleep) during past 24-hour period. Higher score indicates a greater level of sleep disturbance. Self-assessment performed daily on awakening prior to taking study medication.

  3. Change From Baseline in Sleep Interference Score for Fibromyalgia in ITT Population at Week 6

    Time frame: Baseline and Week 6

    DSIS: participant rated 11-point Likert scale ranging from 0 (pain does not interfere with sleep) to 10 (pain completely interferes with sleep) during past 24-hour period. Higher score indicates a greater level of sleep disturbance. Self-assessment performed daily on awakening prior to taking study medication.

  4. Change From Baseline in Sleep Interference Score for Fibromyalgia in PP Population at Week 6

    Time frame: Baseline and Week 6

    DSIS: participant rated 11-point Likert scale ranging from 0 (pain does not interfere with sleep) to 10 (pain completely interferes with sleep) during past 24-hour period. Higher score indicates a greater level of sleep disturbance. Self-assessment performed daily on awakening prior to taking study medication.

  5. Number of Participants With Clinician's Global Impression of Change (CGIC) Scale for NeP in ITT Population

    Time frame: Week 6

    CGIC: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Change is defined as a score of 1 (very much improved), 2 (much improved), 3 (a little improved), 4 (no change), 5 (a little worse), 6 (much worse) or 7 (very much worse) on the scale. Higher score is equal to more affected.

  6. Number of Participants With CGIC Scale for NeP in PP Population

    Time frame: Week 6

    CGIC: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Change is defined as a score of 1 (very much improved), 2 (much improved), 3 (a little improved), 4 (no change), 5 (a little worse), 6 (much worse) or 7 (very much worse) on the scale. Higher score is equal to more affected.

  7. Number of Participants With Patient's Global Impression of Change (PGIC) Scale for NeP in ITT Population

    Time frame: Week 6

    PGIC was defined as participant rated instrument to measure participant's change in overall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse). Change was defined as a score of 1 (very much improved), 2 (much improved), 3 (a little improved), 4 (no change), 5 (a little worse) , 6 (much worse) or 7 (very much worse) on the scale. Higher score is equal to more affected.

  8. Number of Participants With PGIC Scale for NeP in PP Population

    Time frame: Week 6

    PGIC was defined as participant rated instrument to measure participant's change in overall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse). Change was defined as a score of 1 (very much improved), 2 (much improved), 3 (a little improved), 4 (no change), 5 (a little worse) , 6 (much worse) or 7 (very much worse) on the scale. Higher score is equal to more affected.

  9. Number of Participants With CGIC Scale for Fibromyalgia in ITT Population

    Time frame: Week 6

    CGIC: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Change was defined as a score of 1 (very much improved), 2 (much improved), 3 (a little improved), 4 (no change), 5 (a little worse), 6 (much worse) or 7 (very much worse) on the scale. Higher score is equal to more affected.

  10. Number of Participants With CGIC Scale for Fibromyalgia in PP Population

    Time frame: Week 6

    CGIC: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Change was defined as a score of 1 (very much improved), 2 (much improved), 3 (a little improved), 4 (no change), 5 (a little worse), 6 (much worse) or 7 (very much worse) on the scale. Higher score is equal to more affected.

  11. Number of Participants With PGIC Scale for Fibromyalgia in ITT Population

    Time frame: Week 6

    PGIC was defined as participant rated instrument to measure participant's change in overall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse). Change is defined as a score of 1 (very much improved), 2 (much improved), 3 (a little improved), 4 (no change), 5 (a little worse) , 6 (much worse) or 7 (very much worse) on the scale. Higher score is equal to more affected.

  12. Number of Participants With PGIC Scale for Fibromyalgia in PP Population

    Time frame: Week 6

    PGIC was defined as participant rated instrument to measure participant's change in overall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse). Change is defined as a score of 1 (very much improved), 2 (much improved), 3 (a little improved), 4 (no change), 5 (a little worse) , 6 (much worse) or 7 (very much worse) on the scale. Higher score is equal to more affected.

Sponsors and collaborators

Lead sponsor

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

Industry

Registry information

Official study title

Post Marketing Surveillance Study For Observing Safety And Efficacy Of Lyrica

Important dates

Study start
2006
Primary completion
2011
Study completion
2011
First posted
Oct 13, 2010
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.

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