Special Investigation of Pregabalin for Fibromyalgia (Regulatory Post Marketing Commitment Plan)
To collect the efficacy and safety information of Pregabalin on Fibromyalgia patients related to their appropriate use in daily practice.
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Special Investigation of Pregabalin (Lyrica) for Fibromyalgia|
- Number of Participants with Change from Baseline in Clinical Global Impression of Clinical Condition (CGI-C) at Month X [ Time Frame: 12 months ] [ 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:||January 2013|
|Estimated Study Completion Date:||November 2015|
|Estimated Primary Completion Date:||November 2015 (Final data collection date for primary outcome measure)|
Subjects who are treated with pregabalin
The usual adult dosage for oral use begins at 150 mg/day of pregabalin twice daily, and should be gradually increased to 300 mg/day over 1 week or more and then maintained at 300-450 mg/day as needed. Dosage should be adjusted, depending on age or symptoms. However, the daily maximum dose should not be beyond 450 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 pregabalin 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: NCT01773993
|Study Director:||Pfizer CT.gov Call Center||Pfizer|