Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Safety And Efficacy Of Lyrica (Regulatory Post Marketing Commitment Plan) (RAINBOW)

This study is enrolling participants by invitation only.
Information provided by (Responsible Party):
Pfizer Identifier:
First received: December 7, 2010
Last updated: November 24, 2014
Last verified: November 2014

December 7, 2010
November 24, 2014
February 2011
July 2018   (final data collection date for primary outcome measure)
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.
  • The incidence of adverse drug reactions. [ Time Frame: 13 weeks ] [ Designated as safety issue: Yes ]
  • Adverse drug reaction not expected from the LPD (unknown adverse drug reaction). [ Time Frame: 13 weeks ] [ Designated as safety issue: Yes ]
  • Efficacy rate for the patients of NEUROPATHIC PAIN include POSTHERPETIC NEURALGIA. [ Time Frame: 13 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01256593 on Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
Safety And Efficacy Of Lyrica (Regulatory Post Marketing Commitment Plan)
Research For Anti-Neuropathic Pain Treatment In General Practice, Both Efficacy And Safety Of Relief The Pain On Worsening By Lyrica

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.

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.

Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

The patients whom an investigator involving A0081261 prescribes the Lyrica 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
Pregabalin (Lyrica) capsule
Patients administered "Pregabalin capsule".
Intervention: Drug: Pregabalin (Lyrica) capsule
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Enrolling by invitation
July 2018
July 2018   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients need to be administered Lyrica® in order to be enrolled in the surveillance.

Exclusion Criteria:

  • Patients not administered Lyrica®.
Not Provided
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Study Director: Pfizer Call Center Pfizer
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP