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

Peripheral Neuropathic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04171453
• Other study ID #: A0081364
• Status: Recruiting
• Start date: February 3, 2020
• Est. completion date: July 14, 2022

Study information

• Verified date: June 2022
• Source: Viatris Inc.
• Contact: Nam-Eun Kim
• Phone: 82-10-9310-7990
• Email: Nam-Eun.Kim[@]viatris.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: July 14, 2022
• Est. primary completion date: July 14, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

[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.

Related Conditions & MeSH terms

• Neuralgia
• Peripheral Neuropathic Pain

Intervention

Drug:
• Lyrica CR (Pregabalin)
Lyrica CR 82.5mg, 165mg, or 330mg OD

Locations

Country	Name	City	State
Korea, Republic of	Gyeongsang National University Changwon Hospital	Changwon
Korea, Republic of	Chonbuk National University Hospital	Jeonju
Korea, Republic of	Seoul National University Hospital Clinical Research Institute	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Viatris Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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	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.
Secondary	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.
Secondary	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)
Secondary	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)
Secondary	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)

External Links

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