Lyrica (Pregabalin) Korean Post Marketing Surveillance Study

Completed

• Conditions: Epilepsy; Neuropathic Pain; Fibromyalgia; Post-market Surveillance
• Interventions: Drug: pregabalin (Lyrica)

• Registration Number: NCT01220180
• Lead Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

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

Study Timeline

• Study Start: 2006-07
• Study First Submitted: 2010-10-07
• Study First Submitted QC: 2010-10-12
• Study First Posted: 2010-10-13
• Primary Completion: 2011-04
• Study Completion: 2011-04
• Status Verified: 2011-11
• Results First Submitted: 2011-11-03
• Results First Submitted QC: 2011-11-03
• Results First Posted: 2011-12-08
• Last Update Submitted: 2021-01-21
• Last Update Posted: 2021-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4175

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Epilepsy	pregabalin (Lyrica)	-
Neuropathic Pain	pregabalin (Lyrica)	-
Fibromyalgia	pregabalin (Lyrica)	-

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Achieving 28 Days Seizure Free Period in Intent-to Treat (ITT) Population	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	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	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	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	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 Fibromyalgia in PP Population at Week 6	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 NeP in PP Population at Week 6	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	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

Name	Time	Method
Number of Participants With Clinician's Global Impression of Change (CGIC) Scale for NeP in ITT Population	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	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.
Change From Baseline in Sleep Interference Score for NeP in ITT Population at Week 6	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	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	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	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 Patient's Global Impression of Change (PGIC) Scale for NeP in ITT Population	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	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	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	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	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	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.