This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01256593
First received: December 7, 2010
Last updated: September 18, 2017
Last verified: September 2017
December 7, 2010
September 18, 2017
February 2011
July 2017   (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 ]
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 ]
  • Adverse drug reaction not expected from the LPD (unknown adverse drug reaction). [ Time Frame: 13 weeks ]
  • Efficacy rate for the patients of NEUROPATHIC PAIN include POSTHERPETIC NEURALGIA. [ Time Frame: 13 weeks ]
Complete list of historical versions of study NCT01256593 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Safety And Efficacy Of Lyrica (Regulatory Post Marketing Commitment Plan)
Drug Use Investigation Of Lyrica(Regulatory Post Marketing Commitment Plan)
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
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample
The patients whom an investigator involving A0081261 prescribes the Lyrica capsule.
Neuralgia
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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
4000
July 2017
July 2017   (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®.
Sexes Eligible for Study: All
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT01256593
A0081261
No
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
September 2017

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