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

POST-MARKETING SURVEILLANCE (PMS) TO OBSERVE THE SAFETY AND EFFECTIVENESS OF LYRICA(REGISTERED) CR EXTENDED RELEASE TABLETS

Patrocinadores

Patrocinador principal: Pfizer

Fuente Pfizer
Resumen breve

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.

Estado general Active, not recruiting
Fecha de inicio February 3, 2020
Fecha de Terminación April 18, 2022
Fecha de finalización primaria April 18, 2022
Tipo de estudio Observational
Resultado primario
Medida Periodo de tiempo
Number of participants with Adverse Event (AE) Maximum of 12 weeks (window period of 2 weeks) from the time of initial administration of Lyrica CR.
Number of participants with Adverse Drug Reactions (ADRs) Maximum of 12 weeks (window period of 2 weeks) from the time of initial administration of Lyrica CR.
Number of participants with Serious Adverse Event (SAE) Maximum of 12 weeks (window period of 2 weeks) from the time of initial administration of Lyrica CR.
Number of participants with unexpected AEs Maximum of 12 weeks (window period of 2 weeks) from the time of initial administration of Lyrica CR.
Number of participants with unexpected ADRs Maximum of 12 weeks (window period of 2 weeks) from the time of initial administration of Lyrica CR.
Percentage of participants with Adverse Event (AE) Maximum of 12 weeks (window period of 2 weeks) from the time of initial administration of Lyrica CR.
Percentage of participants with Serious Adverse Event (SAE) Maximum of 12 weeks (window period of 2 weeks) from the time of initial administration of Lyrica CR.
Percentage of participants with Adverse Drug Reactions (ADRs) Maximum of 12 weeks (window period of 2 weeks) from the time of initial administration of Lyrica CR.
Percentage of participants with unexpected AEs Maximum of 12 weeks (window period of 2 weeks) from the time of initial administration of Lyrica CR.
Percentage of participants with unexpected ADRs Maximum of 12 weeks (window period of 2 weeks) from the time of initial administration of Lyrica CR.
Resultado secundario
Medida Periodo de tiempo
Severity of pain after administration of Lyrica CR At 12 weeks (window period of 2 weeks) or at the time of drug discontinuation.
Sleep interference status after administration of Lyrica CR At 12 weeks (window period of 2 weeks) or at the time of drug discontinuation.
Patient's Global Impression of Change (PGIC) At the end of the study (At 12 weeks, with window period of 2 weeks)
Clinician's Global Impression of Change At the end of the study (At 12 weeks, with window period of 2 weeks)
Final Effectiveness Evaluation At the end of the study (At 12 weeks, with window period of 2 weeks)
Inscripción 600
Condición
Intervención

Tipo de intervención: Drug

Nombre de intervención: Lyrica CR (Pregabalin)

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

Etiqueta de grupo de brazo: Open-label

Elegibilidad

Método de muestreo: Non-Probability Sample

Criterios:

[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.

Género: All

Edad mínima: 18 Years

Edad máxima: N/A

Voluntarios Saludables: No

Oficial general
Apellido Papel Afiliación
Pfizer CT.gov Call Center Study Director Pfizer
Ubicación
Instalaciones: Pfiizer
Ubicacion Paises

Korea, Republic of

Fecha de verificación

February 2020

Fiesta responsable

Tipo: Sponsor

Tiene acceso ampliado No
Condición Examinar
Grupo de brazo

Etiqueta: Open-label

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

Datos del paciente No
Información de diseño del estudio

Modelo de observación: Other

Perspectiva de tiempo: Prospective

Fuente: ClinicalTrials.gov