Lyrica (Pregabalin) Korean Post Marketing Surveillance Study

CompletedOBSERVATIONAL
Enrollment

4,175

Participants

Timeline

Start Date

July 31, 2006

Primary Completion Date

April 30, 2011

Study Completion Date

April 30, 2011

Conditions
EpilepsyNeuropathic PainFibromyalgiaPost-market Surveillance
Interventions
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.

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."

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.

All Listed Sponsors
lead

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

INDUSTRY

NCT01220180 - Lyrica (Pregabalin) Korean Post Marketing Surveillance Study | Biotech Hunter | Biotech Hunter