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

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.

Study Overview

• Status: Recruiting
• Conditions: Peripheral Neuropathic Pain
• Intervention / Treatment: Drug: Lyrica CR (Pregabalin)

• Study Type: Observational
• Enrollment (Anticipated): 600

Contacts and Locations

• Study Contact: Name: Nam-Eun Kim; Phone Number: 82-10-9310-7990; Email: Nam-Eun.Kim@viatris.com

Study Locations

• Korea, Republic of
  • Changwon, Korea, Republic of
    • Recruiting
    • Gyeongsang National University Changwon Hospital
  • Jeonju, Korea, Republic of
    • Recruiting
    • Chonbuk National University Hospital
  • Seoul, Korea, Republic of
    • Recruiting
    • Seoul National University Hospital Clinical Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

[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 Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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); Lyrica CR 82.5mg, 165mg, or 330mg OD

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Severity of pain after administration of Lyrica CR	The severity of pain will be recorded by daily average pain score in 24 hours recall period, calculated with 11-point Numeric Rating Scale (NRS).	At 12 weeks (window period of 2 weeks) or at the time of drug discontinuation.
Sleep interference status after administration of Lyrica CR	The sleep interference status is recorded by the answer with 11-point Likert scale (0=did not interfere, 10=unable to sleep) from the question, "How much did the pain interfere with your sleep during the past 24 hours?" and the data will be based on the patient's recall	At 12 weeks (window period of 2 weeks) or at the time of drug discontinuation.
Patient's Global Impression of Change (PGIC)	Rating is given by the subject to indicate the impression of change since baseline. This rating is on a 7-point scale that has categories such as 'very much improved', 'much improved', 'a little improved', 'no change', 'a little worse', 'much worse', and 'very much worse'.	At the end of the study (At 12 weeks, with window period of 2 weeks)
Clinician's Global Impression of Change	Rating is given by the investigator to indicate the impression of change since baseline based on the Severity of pain after administration, the Sleep interference status after administration, and the PGIC. This rating is on a 7-point scale that has categories such as 'very much improved', 'much improved', 'a little improved', 'no change', 'a little worse', 'much worse', and 'very much worse'.	At the end of the study (At 12 weeks, with window period of 2 weeks)
Final Effectiveness Evaluation	On the results of the above Clinician's Global Impression of Change, the investigator shall mark 'very much improved', 'much improved', and 'a little improved' as 'valid', or mark 'no change', 'a little worse', 'much worse', and 'very much worse' as 'invalid'.	At the end of the study (At 12 weeks, with window period of 2 weeks)

Collaborators and Investigators

• Sponsor: Viatris Korea

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): February 3, 2020
• Primary Completion (Anticipated): July 14, 2022
• Study Completion (Anticipated): July 14, 2022

Study Registration Dates

• First Submitted: October 10, 2019
• First Submitted That Met QC Criteria: November 19, 2019
• First Posted (Actual): November 21, 2019

Study Record Updates

• Last Update Posted (Actual): June 21, 2022
• Last Update Submitted That Met QC Criteria: June 14, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Neuromuscular Diseases; Peripheral Nervous System Diseases; Neuralgia; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Tranquilizing Agents; Psychotropic Drugs; Membrane Transport Modulators; Anti-Anxiety Agents; Anticonvulsants; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Pregabalin
• Other Study ID Numbers: A0081364

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No