- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01220180
Lyrica (Pregabalin) Korean Post Marketing Surveillance Study
Post Marketing Surveillance Study For Observing Safety And Efficacy Of Lyrica
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Ecologic or Community
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Fibromyalgia
|
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.
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.
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
|
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.
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.
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.
|
Neuropathic Pain
|
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.
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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline through Week 12
|
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.
|
Baseline through Week 12
|
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.
|
Baseline through Week 12
|
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.
|
Baseline through Week 12
|
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.
|
Baseline and Week 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.
|
Baseline and Week 6
|
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.
|
Baseline and Week 6
|
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.
|
Baseline and Week 6
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline and Week 6
|
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.
|
Baseline and Week 6
|
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.
|
Baseline and Week 6
|
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.
|
Baseline and Week 6
|
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.
|
Week 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.
|
Week 6
|
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.
|
Week 6
|
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.
|
Week 6
|
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.
|
Week 6
|
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.
|
Week 6
|
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.
|
Week 6
|
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.
|
Week 6
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Pain
- Neurologic Manifestations
- Musculoskeletal Diseases
- Rheumatic Diseases
- Muscular Diseases
- Neuromuscular Diseases
- Peripheral Nervous System Diseases
- Epilepsy
- Neuralgia
- Fibromyalgia
- Myofascial Pain Syndromes
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Membrane Transport Modulators
- Anti-Anxiety Agents
- Anticonvulsants
- Calcium-Regulating Hormones and Agents
- Calcium Channel Blockers
- Pregabalin
Other Study ID Numbers
- A0081138
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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