Lyrica (Pregabalin) Korean Post Marketing Surveillance Study

Epilepsy Clinical Trial

Official title:

Post Marketing Surveillance Study For Observing Safety And Efficacy Of Lyrica

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01220180
• Other study ID #: A0081138
• Status: Completed
• Start date: July 2006
• Est. completion date: April 2011

Study information

• Verified date: November 2011
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Description:

continuous patients with target disorders in collaborating institutions

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4175
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Epilepsy
• Fibromyalgia
• Myofascial Pain Syndromes
• Neuralgia
• Neuropathic Pain
• Post-market Surveillance

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Achieving 28 Days Seizure Free Period in Intent-to Treat (ITT) Population	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
Primary	Percentage of Participants Achieving 28 Days Seizure Free Period in Per Protocol (PP) Population	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
Primary	Percentage of Participants With Improvement in Seizure Frequency in ITT Population	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
Primary	Percentage of Participants With Improvement in Seizure Frequency in PP Population	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
Primary	Change From Baseline in Daily Pain Score for NeP in ITT Population at 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
Primary	Change From Baseline in Daily Pain Score for NeP in PP Population at 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
Primary	Change From Baseline in Daily Pain Score for Fibromyalgia in ITT Population at 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
Primary	Change From Baseline in Daily Pain Score for Fibromyalgia in PP Population at 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	Change From Baseline in Sleep Interference Score for NeP in ITT Population at 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
Secondary	Change From Baseline in Sleep Interference Score for NeP in PP Population at 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
Secondary	Change From Baseline in Sleep Interference Score for Fibromyalgia in ITT Population at 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
Secondary	Change From Baseline in Sleep Interference Score for Fibromyalgia in PP Population at 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
Secondary	Number of Participants With Clinician's Global Impression of Change (CGIC) Scale for NeP in ITT Population	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
Secondary	Number of Participants With CGIC Scale for NeP in PP Population	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
Secondary	Number of Participants With Patient's Global Impression of Change (PGIC) Scale for NeP in ITT Population	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
Secondary	Number of Participants With PGIC Scale for NeP in PP Population	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
Secondary	Number of Participants With CGIC Scale for Fibromyalgia in ITT Population	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
Secondary	Number of Participants With CGIC Scale for Fibromyalgia in PP Population	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
Secondary	Number of Participants With PGIC Scale for Fibromyalgia in ITT Population	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
Secondary	Number of Participants With PGIC Scale for Fibromyalgia in PP Population	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

External Links

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