NCT01279850

Safety And Efficacy In Long Term Use Of Lyrica (Regulatory Post Marketing Commitment Plan)

SPECIAL INVESTIGATION OF LONG TERM USE OF LYRICA(REGULATORY POST MARKETING COMMITMENT PLAN)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 891 (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 long term use with 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

Patients who fulfill criteria below: 1. Patients who have previously enrolled in A0081261. 2. Patients who have been administered Lyrica for more than 52 weeks.

Conditions

• Neuropathic Pain

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: 2011-08-01
• Primary completion: 2017-07-01
• Completion: 2017-07-01
• First posted: 2011-01-19
• Last updated: 2023-10-10
• Results posted: 2019-05-03

Regulatory

• FDA-regulated drug study