POST-MARKETING SURVEILLANCE (PMS) TO OBSERVE THE SAFETY AND EFFECTIVENESS OF LYRICA(REGISTERED) CR EXTENDED RELEASE TABLETS
Overview
- Phase
- Not Applicable
- Intervention
- Lyrica CR (Pregabalin)
- Conditions
- Peripheral Neuropathic Pain
- Sponsor
- Viatris Korea
- Enrollment
- 600
- Locations
- 3
- Primary Endpoint
- Number of participants with Adverse Event (AE)
- Last Updated
- 3 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Open-label
This study was open-label with only one treatment group. Lyrica CR was prescribed in accordance with usual clinical practice.
Intervention: Lyrica CR (Pregabalin)
Outcomes
Primary Outcomes
Number of participants with Adverse Event (AE)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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)
Time Frame: 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 Outcomes
- Severity of pain after administration of Lyrica CR(At 12 weeks (window period of 2 weeks) or at the time of drug discontinuation.)
- Sleep interference status after administration of Lyrica CR(At 12 weeks (window period of 2 weeks) or at the time of drug discontinuation.)
- Clinician's Global Impression of Change(At the end of the study (At 12 weeks, with window period of 2 weeks))
- Final Effectiveness Evaluation(At the end of the study (At 12 weeks, with window period of 2 weeks))
- Patient's Global Impression of Change (PGIC)(At the end of the study (At 12 weeks, with window period of 2 weeks))