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
  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 ] [ 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.


Secondary Outcome Measures:
  • 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.


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

Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01220180

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

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01220180     History of Changes
Other Study ID Numbers: A0081138
Study First Received: October 7, 2010
Results First Received: November 3, 2011
Last Updated: November 3, 2011
Health Authority: Korea: Korean Food and Drug Administration

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
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants

ClinicalTrials.gov processed this record on April 22, 2014