Post-marketing Surveillance (PMS) to Observe the Safety and Effectiveness of Lyrica CR Extended Release Tablets

Last updated: June 14, 2022
Sponsor: Viatris Korea
Overall Status: Active - Recruiting

Phase

N/A

Condition

Pain (Pediatric)

Pain

Treatment

N/A

Clinical Study ID

NCT04171453
A0081364
  • Ages > 18
  • All Genders

Study Summary

This is an open-label, non-comparative, non-interventional, prospective, and multi-center PMS study to observe safety and effectiveness of Lyrica CR (82.5mg, 165mg, 330mg) in Korean subjects under the actual condition of use. PMS is an obligation to K-MFDS.

Eligibility Criteria

Inclusion

[Inclusion criteria]

To be eligible to enter this study, the subject will have to meet the following inclusion criteria:

  1. Korean patients who have been administered Lyrica CR for the first time according to the current local labeling (indication, dosage and administration).

  2. Subjects who have consented to participate in this study by signing the data privacy statement.

[Exclusion criteria]

Patients meeting any of the following criteria will not be included in the study:

  1. Patients who have deviated from local labeling (indication, dosage and administration) in taking this drug

  2. Renal impairment patients with CLCr less than 30 mL/min or who are undergoing hemodialysis.

  3. Patients who have hypersensitivity to the active substance (pregabalin) or to any of the excipients.

  4. Other patients who are decided to be not prescribed by the investigator under the routine medical practice, considering the balance the overall risk and benefit, for example, patients have suicidal behavior and ideation, or have any risk of these, and/or patients who are in pregnancy or lactation, etc.

Study Design

Total Participants: 600
Study Start date:
February 03, 2020
Estimated Completion Date:
July 14, 2022

Connect with a study center

  • Gyeongsang National University Changwon Hospital

    Changwon,
    Korea, Republic of

    Active - Recruiting

  • Chonbuk National University Hospital

    Jeonju,
    Korea, Republic of

    Active - Recruiting

  • Seoul National University Hospital Clinical Research Institute

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • Pfizer

    Soeul,
    Korea, Republic of

    Site Not Available

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