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

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NCT01279850

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Neuropathic Pain
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
0 +
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Patients not administered Lyrica.

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Advanced Information
Descriptive Information
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:

  1. Patients who have previously enrolled in A0081261.
  2. Patients who have been administered Lyrica for more than 52 weeks.
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
 (submitted: November 13, 2017)		891
Original Estimated Enrollment
 (submitted: January 18, 2011)		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:

  • 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.
Sex/Gender
Sexes Eligible for Study:All
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
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD:No
Plan Description:Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d….
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
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date January 2019