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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open-label | This study was open-label with only one treatment group. Lyrica CR was prescribed in accordance with usual clinical practice. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lyrica CR (Pregabalin) | Drug | Lyrica CR 82.5mg, 165mg, or 330mg OD |
|
| 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". |
| 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 |
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[Inclusion criteria]
To be eligible to enter this study, the subject will have to meet the following inclusion criteria:
[Exclusion criteria]
Patients meeting any of the following criteria will not be included in the study:
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Subjects administered with Lyrica CR as a part of routine treatment who comply with the local labeling.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nam-Eun Kim | Contact | 82-10-9310-7990 | Nam-Eun.Kim@viatris.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gyeongsang National University Changwon Hospital | Recruiting | Changwon | South Korea | |||
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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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.
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| ID | Term |
|---|---|
| D000069583 | Pregabalin |
| ID | Term |
|---|---|
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
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| 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. |
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) |
| Chonbuk National University Hospital |
| Recruiting |
| Jeonju |
| South Korea |
| Seoul National University Hospital Clinical Research Institute | Recruiting | Seoul | South Korea |
| D002264 |
| Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |