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Lyrica (Pregabalin) Korean Post Marketing Surveillance Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01220180
First received: October 7, 2010
Last updated: November 3, 2011
Last verified: November 2011

October 7, 2010
November 3, 2011
July 2006
April 2011   (final data collection date for primary outcome measure)
  • Percentage of Participants Achieving 28 Days Seizure Free Period in Intent-to Treat (ITT) Population [ Time Frame: Baseline through Week 12 ] [ Designated as safety issue: No ]
    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.
  • Percentage of Participants Achieving 28 Days Seizure Free Period in Per Protocol (PP) Population [ Time Frame: Baseline through Week 12 ] [ Designated as safety issue: No ]
    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.
  • Percentage of Participants With Improvement in Seizure Frequency in ITT Population [ Time Frame: Baseline through Week 12 ] [ Designated as safety issue: No ]
    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.
  • Percentage of Participants With Improvement in Seizure Frequency in PP Population [ Time Frame: Baseline through Week 12 ] [ Designated as safety issue: No ]
    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.
  • Change From Baseline in Daily Pain Score for NeP in ITT Population at Week 6 [ Time Frame: Baseline and Week 6 ] [ Designated as safety issue: No ]
    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.
  • Change From Baseline in Daily Pain Score for NeP in PP Population at Week 6 [ Time Frame: Baseline and Week 6 ] [ Designated as safety issue: No ]
    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.
  • Change From Baseline in Daily Pain Score for Fibromyalgia in ITT Population at Week 6 [ Time Frame: Baseline and Week 6 ] [ Designated as safety issue: No ]
    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.
  • Change From Baseline in Daily Pain Score for Fibromyalgia in PP Population at Week 6 [ Time Frame: Baseline and Week 6 ] [ Designated as safety issue: No ]
    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.
  • Percentage of subjects achieving 28 days seizure free period [ Time Frame: 12 +/- 1 weeks ] [ Designated as safety issue: No ]
  • Percentage reduction in seizure frequency [ Time Frame: 12 +/- 1 weeks ] [ Designated as safety issue: No ]
  • Reduction in subjective daily pain score in patients with diabetic peripheral neuropathic pain (DPNP) or fibromyalgia (FM) on 11 point Likert scale [ Time Frame: 6 +/- 1 weeks ] [ Designated as safety issue: No ]
  • Number of patients with spontaneous reporting of adverse events as a measure of safety and tolerability [ Time Frame: 13 + weeks ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01220180 on ClinicalTrials.gov Archive Site
  • Change From Baseline in Sleep Interference Score for NeP in ITT Population at Week 6 [ Time Frame: Baseline and Week 6 ] [ Designated as safety issue: No ]
    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.
  • Change From Baseline in Sleep Interference Score for NeP in PP Population at Week 6 [ Time Frame: Baseline and Week 6 ] [ Designated as safety issue: No ]
    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.
  • Change From Baseline in Sleep Interference Score for Fibromyalgia in ITT Population at Week 6 [ Time Frame: Baseline and Week 6 ] [ Designated as safety issue: No ]
    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.
  • Change From Baseline in Sleep Interference Score for Fibromyalgia in PP Population at Week 6 [ Time Frame: Baseline and Week 6 ] [ Designated as safety issue: No ]
    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.
  • Number of Participants With Clinician's Global Impression of Change (CGIC) Scale for NeP in ITT Population [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
    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.
  • Number of Participants With CGIC Scale for NeP in PP Population [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
    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.
  • Number of Participants With Patient's Global Impression of Change (PGIC) Scale for NeP in ITT Population [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
    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.
  • Number of Participants With PGIC Scale for NeP in PP Population [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
    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.
  • Number of Participants With CGIC Scale for Fibromyalgia in ITT Population [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
    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.
  • Number of Participants With CGIC Scale for Fibromyalgia in PP Population [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
    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.
  • Number of Participants With PGIC Scale for Fibromyalgia in ITT Population [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
    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.
  • Number of Participants With PGIC Scale for Fibromyalgia in PP Population [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
    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.
  • Sleep interference in patients with DPNP or FM [ Time Frame: 6 +/- 1 weeks ] [ Designated as safety issue: No ]
  • Clinician's Global Impression of Improvement (CGI-I) and Patient's Global Impression of Improvement (PGI-I) [ Time Frame: 6 +/- 1 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Lyrica (Pregabalin) Korean Post Marketing Surveillance Study
Post Marketing Surveillance Study For Observing Safety And Efficacy Of Lyrica

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

continuous patients with target disorders in collaborating institutions

Observational
Observational Model: Ecologic or Community
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Korean adult patients with epilepsy, neuropathic pain or fibromyalgia, prescribed pregabalin for within label use

  • Epilepsy
  • Neuropathic Pain
  • Fibromyalgia
  • Post-market Surveillance
  • Drug: pregabalin (Lyrica)
    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.
  • Drug: pregabalin (Lyrica)

    Peripheral neuropathic pain: Pregabalin treatment can be started at 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 an interval of 3 to 7 days, and if needed, to a maximum dose of 600 mg per day after an additional 7-day interval.

    Central neuropathic pain: Pregabalin treatment can be started at 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 an interval of 1 week, and if needed, to a maximum dose of 600 mg per day after an additional 1 week interval. In case that tolerability could not be shown in the targeted daily dose, dose reduction may be considered.

  • Drug: pregabalin (Lyrica)
    The recommended dose of pregabalin for fibromyalgia is 300 to 450 mg/day. Dosing should begin at 75 mg two times a day (150 mg/day) and may be increased to 150 mg two times a day (300 mg/day) within 1 week based on efficacy and tolerability. Subjects who do not experience sufficient benefit with 300 mg/day may be further increased to 225 mg two times a day (450 mg/day). Treatment with doses above 450 mg/day is not recommended.
  • Epilepsy
    Intervention: Drug: pregabalin (Lyrica)
  • Neuropathic Pain
    Intervention: Drug: pregabalin (Lyrica)
  • Fibromyalgia
    Intervention: Drug: pregabalin (Lyrica)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
4175
April 2011
April 2011   (final data collection date for primary outcome measure)

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.
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01220180
A0081138
No
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP