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

NCT04171453 | Unknown FDA Drug

• 1 other identifier: A0081364
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Peripheral Neuropathic Pain

Outcome Measures

Primary Outcomes (10)

• Number of participants with Adverse Event (AE)

  Duration, severity, outcome and causal relationship of the AE with the study drug (Lyrica CR) will be measured.

  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)

  All the AEs, except for those with the causal relationship of 'Unlikely', are considered as 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)

  SAE is any untoward medical occurrence attributed to Lyrica CR in a participant who received the study drug. A serious ADR was an ADR resulting in any of the following outcomes or deemed signification for any other reason: death; life-threatening; requires inpatient hospitalization or prolongation of hospitalization; results in persistent or significant disability/incapacity; results in congenital anomaly/birth defects; is an important medical event.

  Maximum of 12 weeks (window period of 2 weeks) from the time of initial administration of Lyrica CR.

• Number of participants with unexpected AEs

  Unexpected AEs will be classified by medical review with reference to the local product document. Events already included in the "Precautions for use" section of the local product document will be classified as "expected". All other events that are not included in the "Precautions for use" section of the local product document will be classified as "unexpected".

  Maximum of 12 weeks (window period of 2 weeks) from the time of initial administration of Lyrica CR.

• Number of participants with unexpected ADRs

  Unexpected ADRs will be classified by medical review with reference to the local product document. Events already included in the "Precautions for use" section of the local product document will be classified as "expected". All other events that are not included in the "Precautions for use" section of the local product document will be classified as "unexpected".

  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)

  Duration, severity, outcome and causal relationship of the AE with the study drug (Lyrica CR) will be measured.

  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)

  SAE is any untoward medical occurrence attributed to Lyrica CR in a participant who received the study drug. A serious ADR was an ADR resulting in any of the following outcomes or deemed signification for any other reason: death; life-threatening; requires inpatient hospitalization or prolongation of hospitalization; results in persistent or significant disability/incapacity; results in congenital anomaly/birth defects; is an important medical event.

  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)

  All the AEs, except for those with the causal relationship of 'Unlikely', are considered as 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

  Unexpected AEs will be classified by medical review with reference to the local product document. Events already included in the "Precautions for use" section of the local product document will be classified as "expected". All other events that are not included in the "Precautions for use" section of the local product document will be classified as "unexpected".

  Maximum of 12 weeks (window period of 2 weeks) from the time of initial administration of Lyrica CR.

• Percentage of participants with unexpected ADRs

  Unexpected ADRs will be classified by medical review with reference to the local product document. Events already included in the "Precautions for use" section of the local product document will be classified as "expected". All other events that are not included in the "Precautions for use" section of the local product document will be classified as "unexpected".

  Maximum of 12 weeks (window period of 2 weeks) from the time of initial administration of Lyrica CR.

Secondary Outcomes (5)

• 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)

Study Arms (1)

Open-label

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

Drug: Lyrica CR (Pregabalin)

Interventions

Lyrica CR (Pregabalin) DRUG

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

Open-label

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects administered with Lyrica CR as a part of routine treatment who comply with the local labeling.

You may qualify if:

• Korean patients who have been administered Lyrica CR for the first time according to the current local labeling (indication, dosage and administration).
• Subjects who have consented to participate in this study by signing the data privacy statement.

You may not qualify if:

• Patients meeting any of the following criteria will not be included in the study:
• Patients who have deviated from local labeling (indication, dosage and administration) in taking this drug
• Renal impairment patients with CLCr less than 30 mL/min or who are undergoing hemodialysis.
• Patients who have hypersensitivity to the active substance (pregabalin) or to any of the excipients.
• 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.

Sponsors & Collaborators

• Viatris Korea: lead

Study Sites (3)

Gyeongsang National University Changwon Hospital

Changwon, South Korea

RECRUITING

Chonbuk National University Hospital

Jeonju, South Korea

RECRUITING

Seoul National University Hospital Clinical Research Institute

Seoul, South Korea

RECRUITING

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Interventions

Pregabalin

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Central Study Contacts

Nam-Eun Kim

CONTACT

82-10-9310-7990; Nam-Eun.Kim@viatris.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2019
• First Posted: November 21, 2019
• Study Start: February 3, 2020
• Primary Completion: July 14, 2022
• Study Completion: July 14, 2022
• Last Updated: June 21, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

KR (3)