Clinical trial NCT01220180: Lyrica (Pregabalin) Korean Post Marketing Surveillance Study
Official title: Post Marketing Surveillance Study For Observing Safety And Efficacy Of Lyrica
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Epilepsy
Neuropathic Pain
Fibromyalgia
Post-market Surveillance
Keywords: epilepsy
neuropathic pain
fibromyalgia
post-market surveillance
prospective observational
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-10-13
Enrollment: 4175
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Korean adult patients with epilepsy, neuropathic pain or fibromyalgia, prescribed pregabalin for within label use

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

Detailed description: continuous patients with target disorders in collaborating institutions

Eligibility 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.

Primary outcomes:
measure: Percentage of Participants Achieving 28 Days Seizure Free Period in Intent-to Treat (ITT) Population
timeFrame: Baseline through Week 12
measure: Percentage of Participants Achieving 28 Days Seizure Free Period in Per Protocol (PP) Population
timeFrame: Baseline through Week 12
measure: Percentage of Participants With Improvement in Seizure Frequency in ITT Population
timeFrame: Baseline through Week 12
measure: Percentage of Participants With Improvement in Seizure Frequency in PP Population
timeFrame: Baseline through Week 12
measure: Change From Baseline in Daily Pain Score for NeP in ITT Population at Week 6
timeFrame: Baseline and Week 6
measure: Change From Baseline in Daily Pain Score for NeP in PP Population at Week 6
timeFrame: Baseline and Week 6
measure: Change From Baseline in Daily Pain Score for Fibromyalgia in ITT Population at Week 6
timeFrame: Baseline and Week 6
measure: Change From Baseline in Daily Pain Score for Fibromyalgia in PP Population at Week 6
timeFrame: Baseline and Week 6
Secondary outcomes:
measure: Change From Baseline in Sleep Interference Score for NeP in ITT Population at Week 6
timeFrame: Baseline and Week 6
measure: Change From Baseline in Sleep Interference Score for NeP in PP Population at Week 6
timeFrame: Baseline and Week 6
measure: Change From Baseline in Sleep Interference Score for Fibromyalgia in ITT Population at Week 6
timeFrame: Baseline and Week 6
measure: Change From Baseline in Sleep Interference Score for Fibromyalgia in PP Population at Week 6
timeFrame: Baseline and Week 6
measure: Number of Participants With Clinician's Global Impression of Change (CGIC) Scale for NeP in ITT Population
timeFrame: Week 6
measure: Number of Participants With CGIC Scale for NeP in PP Population
timeFrame: Week 6
measure: Number of Participants With Patient's Global Impression of Change (PGIC) Scale for NeP in ITT Population
timeFrame: Week 6
measure: Number of Participants With PGIC Scale for NeP in PP Population
timeFrame: Week 6
measure: Number of Participants With CGIC Scale for Fibromyalgia in ITT Population
timeFrame: Week 6
measure: Number of Participants With CGIC Scale for Fibromyalgia in PP Population
timeFrame: Week 6
measure: Number of Participants With PGIC Scale for Fibromyalgia in ITT Population
timeFrame: Week 6
measure: Number of Participants With PGIC Scale for Fibromyalgia in PP Population
timeFrame: Week 6
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: