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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-02-03

Study Completion Date

2022-07-14

Brief Summary

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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.

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Detailed Description

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Conditions

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Peripheral Neuropathic Pain

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Open-label

This study was open-label with only one treatment group. Lyrica CR was prescribed in accordance with usual clinical practice.

Lyrica CR (Pregabalin)

Intervention Type DRUG

Lyrica CR 82.5mg, 165mg, or 330mg OD

Interventions

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Lyrica CR (Pregabalin)

Lyrica CR 82.5mg, 165mg, or 330mg OD

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No