NCT01256593

Safety And Efficacy Of Lyrica (Regulatory Post Marketing Commitment Plan)

DRUG USE INVESTIGATION OF LYRICA(REGULATORY POST MARKETING COMMITMENT PLAN)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 3,827 (actual)
• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc. · Industry
• Sex: All
• Age: 0 Days
• Healthy volunteers: Not accepted

Summary

The objective of this Investigation is to evaluate the safety and efficacy of Lyrica in medical practice. Also, occurrence of unknown and known adverse drug reactions (ADRs) in subjects treated with Lyrica will be monitored during the survey period, and whether an additional treatment outcome investigation and/or a post-marketing clinical study is required in the future will be determined.

Detailed description

All the patients whom an investigator prescribes the first Lyrica® should be registered consecutively until the number of subjects reaches target number in order to extract patients enrolled into the investigation at random.

Conditions

• Neuralgia

Interventions

Type	Name	Description
DRUG	Pregabalin (Lyrica) capsule	Lyrica® Capsules depending on the investigator prescription. Frequency and duration are according to Package Insert as follows. "The usual adult dosage for oral use begins at 150 mg/day of pregabalin in twice daily, and should be gradually increased to 300 mg/day over 1 week or more and should be orally administered twice daily. Dosage should be adjusted, depending on age or symptoms. However, the daily maximum dose should not be beyond 600 mg, and should be orally administered twice daily".

Timeline

• Start date: 2011-02-05
• Primary completion: 2017-07-31
• Completion: 2017-07-31
• First posted: 2010-12-08
• Last updated: 2023-09-15
• Results posted: 2019-05-07

Regulatory

• FDA-regulated drug study