Safety And Efficacy In Long Term Use Of Lyrica (Regulatory Post Marketing Commitment Plan) (RAINBOW-L)
|ClinicalTrials.gov Identifier: NCT01279850|
Recruitment Status : Completed
First Posted : January 19, 2011
Last Update Posted : November 29, 2017
|Condition or disease||Intervention/treatment|
|Neuropathic Pain||Drug: Pregabalin (Lyrica) capsule|
Patients who fulfill criteria below:
- Patients who have previously enrolled in A0081261.
- Patients who have been administered Lyrica for more than 52 weeks.
|Study Type :||Observational|
|Actual Enrollment :||891 participants|
|Official Title:||Special Investigation Of Long Term Use Of Lyrica(Regulatory Post Marketing Commitment Plan)|
|Actual Study Start Date :||August 29, 2011|
|Actual Primary Completion Date :||July 31, 2017|
|Actual Study Completion Date :||July 31, 2017|
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
- Number of Participants with Change from Baseline in Clinical Global Impression of Clinical Condition (CGI-C) at Month X [ Time Frame: MAX 104 weeks ]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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01279850
|Study Director:||Pfizer CT.gov Call Center||Pfizer|