Safety And Efficacy In Long Term Use Of Lyrica (Regulatory Post Marketing Commitment Plan) (RAINBOW-L)

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01279850
First received: January 18, 2011
Last updated: March 25, 2014
Last verified: March 2014

January 18, 2011
March 25, 2014
September 2011
September 2014   (final data collection date for primary outcome measure)
Number of Participants with Change from Baseline in Clinical Global Impression of Clinical Condition (CGI-C) at Month X [ Time Frame: MAX 104 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 for long term use. [ Time Frame: MAX 104 weeks ] [ Designated as safety issue: Yes ]
  • Adverse drug reaction not expected from the LPD (unknown adverse drug reaction) for long term use. [ Time Frame: MAX 104 weeks ] [ Designated as safety issue: Yes ]
  • Efficacy rate for the patients of NEUROPATHIC PAIN include POSTHERPETIC NEURALGIA for long term use. [ Time Frame: MAX 104 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01279850 on ClinicalTrials.gov Archive Site
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Safety And Efficacy In Long Term Use 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 Long Time Use

The objective of this investigation is to evaluate the safety and efficacy of long term use with 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.

Patients who fulfill criteria below:

  1. Patients who have previously enrolled in A0081261.
  2. Patients who have been administered Lyrica for more than 52 weeks.
Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Probability Sample

The patients whom an investigator involving A0081262 prescribes the Lyrica capsule.

And the patients who are administered Lyrica for over 52 weeks (MAX 104 weeks).

Neuropathic Pain
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
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
310
September 2014
September 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients need to be administered by Lyrica for over 52 weeks in order to be enrolled in the surveillance.

Exclusion Criteria:

  • Patients not administered Lyrica.
Both
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No
Contact information is only displayed when the study is recruiting subjects
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NCT01279850
A0081262
No
Pfizer
Pfizer
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Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2014

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