Safety And Efficacy Of Lyrica (Regulatory Post Marketing Commitment Plan) (RAINBOW)
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.
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Drug Use Investigation Of Lyrica(Regulatory Post Marketing Commitment Plan)|
- Change in Clinical Global Impression of Clinical Condition (CGI-C) From Baseline at Month X [ Time Frame: 13 weeks ] [ Designated as safety issue: No ]The CGI-C scale measures a physician's global impression of a participant's clinical condition at final visit in terms of change relative to the start of treatment (CGI-C). At final visit, the participants CGI-C will be categorized into a three point scale as: improvement: CGI response of very much improved, much improved or minimally improved; no change: CGI response of no change; worsening: CGI response of very much worse, much worse or minimally worse.
|Study Start Date:||February 2011|
|Estimated Study Completion Date:||July 2018|
|Estimated Primary Completion Date:||July 2018 (Final data collection date for primary outcome measure)|
Pregabalin (Lyrica) capsule
Patients administered "Pregabalin capsule".
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".
Other Name: Lyrica® Capsules 25 mg, Lyrica® Capsules 75 mg, Lyrica® Capsules 150 mg
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01256593
|Study Director:||Pfizer CT.gov Call Center||Pfizer|