Safety And Efficacy In Long Term Use Of Lyrica (Regulatory Post Marketing Commitment Plan)
This trial is active, not recruiting.
|Treatment||pregabalin (lyrica) capsule|
|Start date||August 2011|
|End date||June 2017|
|Trial size||1000 participants|
|Trial identifier||NCT01279850, A0081262|
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.
Number of Participants with Change from Baseline in Clinical Global Impression of Clinical Condition (CGI-C) at Month X
time frame: MAX 104 weeks
All participants of any age.
Inclusion Criteria: - Patients need to be administered by Lyrica for over 52 weeks in order to be enrolled in the surveillance. Exclusion Criteria: - Patients not administered Lyrica.
|Official title||Special Investigation Of Long Term Use Of Lyrica(Regulatory Post Marketing Commitment Plan)|
|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.|
Call for more information