Lyrica (Pregabalin) Korean Post Marketing Surveillance Study

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NCT01220180

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Epilepsy, Neuropathic Pain, Fibromyalgia, Post-market Surveillance
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

- Any patient treated with pregabalin for an approved indication by Korean Food and Drug Administration

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


- 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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Epilepsy, Neuropathic Pain, Fibromyalgia, Post-market SurveillanceLyrica (Pregabalin) Korean Post Marketing Surveillance Study
NCT01220180
ALL GENDERS
0+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
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
  • Epilepsy
  • Neuropathic Pain
  • Fibromyalgia
  • Post-market Surveillance
Intervention
  • Drug: pregabalin (Lyrica)
    Pregabalin treatment can be started with a dose of 150 mg per day. Based on individual subject response and tolerability, the dosage may be increased to 300 mg per day after 1 week. The maximum dosage of 600 mg per day may be achieved after an additional week.
  • Drug: pregabalin (Lyrica)

    Peripheral neuropathic pain: Pregabalin treatment can be started at a dose of 150 mg per day. Based on individual subject response and tolerability, the dosage may be increased to 300 mg per day after an interval of 3 to 7 days, and if needed, to a maximum dose of 600 mg per day after an additional 7-day interval.

    Central neuropathic pain: Pregabalin treatment can be started at a dose of 150 mg per day. Based on individual subject response and tolerability, the dosage may be increased to 300 mg per day after an interval of 1 week, and if needed, to a maximum dose of 600 mg per day after an additional 1 week interval. In case that tolerability could not be shown in the targeted daily dose, dose reduction may be considered.

  • Drug: pregabalin (Lyrica)
    The recommended dose of pregabalin for fibromyalgia is 300 to 450 mg/day. Dosing should begin at 75 mg two times a day (150 mg/day) and may be increased to 150 mg two times a day (300 mg/day) within 1 week based on efficacy and tolerability. Subjects who do not experience sufficient benefit with 300 mg/day may be further increased to 225 mg two times a day (450 mg/day). Treatment with doses above 450 mg/day is not recommended.
Study Groups/Cohorts
  • Epilepsy
    Intervention: Drug: pregabalin (Lyrica)
  • Neuropathic Pain
    Intervention: Drug: pregabalin (Lyrica)
  • Fibromyalgia
    Intervention: Drug: pregabalin (Lyrica)
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: October 3, 2011)		4175
Original Estimated Enrollment
 (submitted: October 12, 2010)		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:

  • Any patient treated with pregabalin for an approved indication by Korean Food and Drug Administration

Exclusion Criteria:

  • Non-consenting
  • Hypersensitivity to the active substance or to any of the excipients
  • galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.
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 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 ( 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 November 2011