Peripheral Neuropathic Pain
Conditions
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.
Interventions
DRUGLyrica CR (Pregabalin)
Lyrica CR 82.5mg, 165mg, or 330mg OD
Sponsors
Viatris Korea
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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 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. |
| 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 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 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 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) |
| 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 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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'. |
| 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'. |
| 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). |
Countries
South Korea
Contacts
Primary ContactNam-Eun Kim
Outcome results
None listed