Clinical trial NCT04171453: Post-marketing Surveillance (PMS) to Observe the Safety and Effectiveness of Lyrica CR Extended Release Tablets
Official title: POST-MARKETING SURVEILLANCE (PMS) TO OBSERVE THE SAFETY AND EFFECTIVENESS OF LYRICA(REGISTERED) CR EXTENDED RELEASE TABLETS
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Peripheral Neuropathic Pain
Lead sponsor: Viatris Inc.
Sponsor class: INDUSTRY
First posted: 2019-11-21
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects administered with Lyrica CR as a part of routine treatment who comply with the local labeling.

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.


Eligibility criteria: \[Inclusion criteria\]

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.

Primary outcomes:
measure: Number of participants with Adverse Event (AE)
timeFrame: Maximum of 12 weeks (window period of 2 weeks) from the time of initial administration of Lyrica CR.
measure: Number of participants with Adverse Drug Reactions (ADRs)
timeFrame: Maximum of 12 weeks (window period of 2 weeks) from the time of initial administration of Lyrica CR.
measure: Number of participants with Serious Adverse Event (SAE)
timeFrame: Maximum of 12 weeks (window period of 2 weeks) from the time of initial administration of Lyrica CR.
measure: Number of participants with unexpected AEs
timeFrame: Maximum of 12 weeks (window period of 2 weeks) from the time of initial administration of Lyrica CR.
measure: Number of participants with unexpected ADRs
timeFrame: Maximum of 12 weeks (window period of 2 weeks) from the time of initial administration of Lyrica CR.
measure: Percentage of participants with Adverse Event (AE)
timeFrame: Maximum of 12 weeks (window period of 2 weeks) from the time of initial administration of Lyrica CR.
measure: Percentage of participants with Serious Adverse Event (SAE)
timeFrame: Maximum of 12 weeks (window period of 2 weeks) from the time of initial administration of Lyrica CR.
measure: Percentage of participants with Adverse Drug Reactions (ADRs)
timeFrame: Maximum of 12 weeks (window period of 2 weeks) from the time of initial administration of Lyrica CR.
measure: Percentage of participants with unexpected AEs
timeFrame: Maximum of 12 weeks (window period of 2 weeks) from the time of initial administration of Lyrica CR.
measure: Percentage of participants with unexpected ADRs
timeFrame: Maximum of 12 weeks (window period of 2 weeks) from the time of initial administration of Lyrica CR.
Secondary outcomes:
measure: Severity of pain after administration of Lyrica CR
timeFrame: At 12 weeks (window period of 2 weeks) or at the time of drug discontinuation.
measure: Sleep interference status after administration of Lyrica CR
timeFrame: At 12 weeks (window period of 2 weeks) or at the time of drug discontinuation.
measure: Patient's Global Impression of Change (PGIC)
timeFrame: At the end of the study (At 12 weeks, with window period of 2 weeks)
measure: Clinician's Global Impression of Change
timeFrame: At the end of the study (At 12 weeks, with window period of 2 weeks)
measure: Final Effectiveness Evaluation
timeFrame: At the end of the study (At 12 weeks, with window period of 2 weeks)
Other outcomes:
Locations:
city: Changwon
country: Korea, Republic of
facility: Gyeongsang National University Changwon Hospital
city: Jeonju
country: Korea, Republic of
facility: Chonbuk National University Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital Clinical Research Institute
Study officials:
References: