NCT01220180

Lyrica (Pregabalin) Korean Post Marketing Surveillance Study

Post Marketing Surveillance Study For Observing Safety And Efficacy Of Lyrica

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 4,175 (actual)
• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc. · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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

Conditions

• Epilepsy
• Neuropathic Pain
• Fibromyalgia
• Post-market Surveillance

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2006-07-01
• Primary completion: 2011-04-01
• Completion: 2011-04-01
• First posted: 2010-10-13
• Last updated: 2021-01-25
• Results posted: 2011-12-08