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

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ClinicalTrials.gov Identifier: NCT01279850
Recruitment Status : Completed
First Posted : January 19, 2011
Last Update Posted : November 29, 2017
Information provided by (Responsible Party):

January 18, 2011
January 19, 2011
November 29, 2017
August 29, 2011
July 31, 2017   (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 ]
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 ]
  • Adverse drug reaction not expected from the LPD (unknown adverse drug reaction) for long term use. [ Time Frame: MAX 104 weeks ]
  • Efficacy rate for the patients of NEUROPATHIC PAIN include POSTHERPETIC NEURALGIA for long term use. [ Time Frame: MAX 104 weeks ]
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)
Special Investigation Of Long Term Use Of Lyrica(Regulatory Post Marketing Commitment Plan)
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 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.
July 31, 2017
July 31, 2017   (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.
Sexes Eligible for Study: All
Child, Adult, Senior
Contact information is only displayed when the study is recruiting subjects
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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
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Study Director: Pfizer CT.gov Call Center Pfizer
November 2017