Safety And Efficacy In Long Term Use Of Lyrica (Regulatory Post Marketing Commitment Plan)
NCT01279850
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- Patients need to be administered by Lyrica for over 52 weeks in order to be enrolled in the surveillance.
- Patients not administered Lyrica.
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Descriptive Information | |||||
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Brief Title | Safety And Efficacy In Long Term Use Of Lyrica (Regulatory Post Marketing Commitment Plan) | ||||
Official Title | SPECIAL INVESTIGATION OF LONG TERM USE OF LYRICA(REGULATORY POST MARKETING COMMITMENT PLAN) | ||||
Brief Summary | 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. | ||||
Detailed Description | Patients who fulfill criteria below:
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Study Type | Observational | ||||
Study Design | Observational Model: Case-Only Time Perspective: Prospective | ||||
Target Follow-Up Duration | Not Provided | ||||
Biospecimen | Not Provided | ||||
Sampling Method | Probability Sample | ||||
Study Population | 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). | ||||
Condition | Neuropathic Pain | ||||
Intervention | 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 | ||||
Study Groups/Cohorts | Pregabalin (Lyrica) capsule
Patients administered "Pregabalin capsule". Intervention: Drug: Pregabalin (Lyrica) capsule | ||||
Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||
Recruitment Information | |||||
Recruitment Status | Completed | ||||
Actual Enrollment | 891 | ||||
Original Estimated Enrollment | 300 | ||||
Actual Study Completion Date | July 2017 | ||||
Actual Primary Completion Date | July 2017 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | Child, Adult, Older Adult | ||||
Accepts Healthy Volunteers | No | ||||
Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries | Not Provided | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number | NCT01279850 | ||||
Other Study ID Numbers | A0081262 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement |
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Responsible Party | Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. ) | ||||
Study Sponsor | Pfizer's Upjohn has merged with Mylan to form Viatris Inc. | ||||
Collaborators | Not Provided | ||||
Investigators |
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PRS Account | Pfizer | ||||
Verification Date | January 2019 |