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

• Conditions: Peripheral Neuropathic Pain
• Interventions: Drug: Lyrica CR (Pregabalin)

• Registration Number: NCT04171453
• Lead Sponsor: Viatris Korea

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-10-10
• Study First Submitted QC: 2019-11-19
• Study First Posted: 2019-11-21
• Study Start: 2020-02-03
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-14
• Last Update Posted: 2022-06-21
• Primary Completion: 2022-07-14
• Study Completion: 2022-07-14

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Open-label	Lyrica CR (Pregabalin)	This study was open-label with only one treatment group. Lyrica CR was prescribed in accordance with usual clinical practice.

Primary Outcome Measures

Name	Time	Method
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.	Duration, severity, outcome and causal relationship of the AE with the study drug (Lyrica CR) will be measured.
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.	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.
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.	All the AEs, except for those with the causal relationship of 'Unlikely', are considered as adverse drug reactions (ADRs)
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.	All the AEs, except for those with the causal relationship of 'Unlikely', are considered as adverse drug reactions (ADRs)
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.	Duration, severity, outcome and causal relationship of the AE with the study drug (Lyrica CR) will be measured.
Percentage of participants with unexpected AEs	Maximum of 12 weeks (window period of 2 weeks) from the time of initial administration of Lyrica CR.	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".
Percentage of participants with unexpected ADRs	Maximum of 12 weeks (window period of 2 weeks) from the time of initial administration of Lyrica CR.	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".
Number of participants with unexpected AEs	Maximum of 12 weeks (window period of 2 weeks) from the time of initial administration of Lyrica CR.	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".
Number of participants with unexpected ADRs	Maximum of 12 weeks (window period of 2 weeks) from the time of initial administration of Lyrica CR.	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".
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.	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.

Secondary Outcome Measures

Name	Time	Method
Severity of pain after administration of Lyrica CR	At 12 weeks (window period of 2 weeks) or at the time of drug discontinuation.	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).
Sleep interference status after administration of Lyrica CR	At 12 weeks (window period of 2 weeks) or at the time of drug discontinuation.	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
Clinician's Global Impression of Change	At the end of the study (At 12 weeks, with window period of 2 weeks)	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'.
Final Effectiveness Evaluation	At the end of the study (At 12 weeks, with window period of 2 weeks)	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'.
Patient's Global Impression of Change (PGIC)	At the end of the study (At 12 weeks, with window period of 2 weeks)	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'.

Trial Locations

Locations (3)

Seoul National University Hospital Clinical Research Institute; 🇰🇷 Seoul, Korea, Republic of

Gyeongsang National University Changwon Hospital; 🇰🇷 Changwon, Korea, Republic of

Chonbuk National University Hospital; 🇰🇷 Jeonju, Korea, Republic of