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Lyrica (Pregabalin) Korean Post Marketing Surveillance Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01220180
First Posted: October 13, 2010
Last Update Posted: December 8, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Pfizer
  Purpose
This study collects post-marketing safety and efficacy surveillance data in real world clinical use of pregabalin for its approved indications in Korea.

Condition Intervention
Epilepsy Neuropathic Pain Fibromyalgia Post-market Surveillance Drug: pregabalin (Lyrica)

Study Type: Observational
Study Design: Observational Model: Ecologic or Community
Time Perspective: Prospective
Official Title: Post Marketing Surveillance Study For Observing Safety And Efficacy Of Lyrica

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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 Outcome Measures:
  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.


Enrollment: 4175
Study Start Date: July 2006
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Epilepsy 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.
Neuropathic Pain 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.

Fibromyalgia 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.

Detailed Description:
continuous patients with target disorders in collaborating institutions
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Korean adult patients with epilepsy, neuropathic pain or fibromyalgia, prescribed pregabalin for within label use
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01220180


Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01220180     History of Changes
Other Study ID Numbers: A0081138
First Submitted: October 7, 2010
First Posted: October 13, 2010
Results First Submitted: November 3, 2011
Results First Posted: December 8, 2011
Last Update Posted: December 8, 2011
Last Verified: November 2011

Keywords provided by Pfizer:
epilepsy
neuropathic pain
fibromyalgia
post-market surveillance
prospective observational

Additional relevant MeSH terms:
Epilepsy
Fibromyalgia
Myofascial Pain Syndromes
Neuralgia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Pain
Neurologic Manifestations
Peripheral Nervous System Diseases
Signs and Symptoms
Pregabalin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs