Lyrica (Pregabalin) Korean Post Marketing Surveillance Study
NCT01220180
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
- Any patient treated with pregabalin for an approved indication by Korean Food and Drug Administration
- Non-consenting
- Hypersensitivity to the active substance or to any of the excipients
- galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.
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Descriptive Information | ||||
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Brief Title | Lyrica (Pregabalin) Korean Post Marketing Surveillance Study | |||
Official Title | Post Marketing Surveillance Study For Observing Safety And Efficacy Of Lyrica | |||
Brief Summary | This study collects post-marketing safety and efficacy surveillance data in real world clinical use of pregabalin for its approved indications in Korea. | |||
Detailed Description | continuous patients with target disorders in collaborating institutions | |||
Study Type | Observational | |||
Study Design | Observational Model: Ecologic or Community Time Perspective: Prospective | |||
Target Follow-Up Duration | Not Provided | |||
Biospecimen | Not Provided | |||
Sampling Method | Non-Probability Sample | |||
Study Population | Korean adult patients with epilepsy, neuropathic pain or fibromyalgia, prescribed pregabalin for within label use | |||
Condition |
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Intervention |
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Study Groups/Cohorts |
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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 | 4175 | |||
Original Estimated Enrollment | 4500 | |||
Actual Study Completion Date | April 2011 | |||
Actual Primary Completion Date | April 2011 (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 | NCT01220180 | |||
Other Study ID Numbers | A0081138 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Pfizer | |||
Study Sponsor | Pfizer | |||
Collaborators | Not Provided | |||
Investigators |
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PRS Account | Pfizer | |||
Verification Date | November 2011 |