Peripheral Neuropathic PainNCT04171453
Post-marketing Surveillance (PMS) to Observe the Safety and Effectiveness of Lyrica CR Extended Release Tablets
An observational study of Peripheral Neuropathic Pain, run by Viatris Korea at 3 sites in South Korea.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Neuropathic Pain
- What is being tested?
- Lyrica CR (Pregabalin)
- How many people
- 600 participants
- Where
- 3 sitesSouth Korea
- Study dates
- 3 Feb 2020to 14 Jul 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects administered with Lyrica CR as a part of routine treatment who comply with the local labeling.
[Inclusion criteria]
To be eligible to enter this study, the subject will have to meet the following inclusion criteria:
- Korean patients who have been administered Lyrica CR for the first time according to the current local labeling (indication, dosage and administration).
- 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:
- Patients who have deviated from local labeling (indication, dosage and administration) in taking this drug
- Renal impairment patients with CLCr less than 30 mL/min or who are undergoing hemodialysis.
- Patients who have hypersensitivity to the active substance (pregabalin) or to any of the excipients.
- 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.
Trial locations and contacts
3 sites in 1 country.
South Korea3 sites, 3 recruiting
- Recruiting
Gyeongsang National University Changwon Hospital
Changwon
- Recruiting
Chonbuk National University Hospital
Jeonju
- Recruiting
Seoul National University Hospital Clinical Research Institute
Seoul
About this study
Official title: POST-MARKETING SURVEILLANCE (PMS) TO OBSERVE THE SAFETY AND EFFECTIVENESS OF LYRICA(REGISTERED) CR EXTENDED RELEASE TABLETS
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.
- Conditions
- Peripheral Neuropathic Pain
- Being tested
- Lyrica CR (Pregabalin)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lyrica CR (Pregabalin)Drug
Lyrica CR 82.5mg, 165mg, or 330mg OD
| Study group | Role | What they receive |
|---|---|---|
| Open-label | This study was open-label with only one treatment group. Lyrica CR was prescribed in accordance with usual clinical practice. Receives: Drug: Lyrica CR (Pregabalin) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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)
Measured: 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.
Measured: 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".
Measured: 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".
Measured: 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.
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.
Measured: 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)
Measured: 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".
Measured: 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".
Measured: Maximum of 12 weeks (window period of 2 weeks) from the time of initial administration of Lyrica CR.
Secondary outcomes (5)
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).
Measured: At 12 weeks (window period of 2 weeks) or at the time of drug discontinuation.
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
Measured: 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'.
Measured: 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'.
Measured: 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'.
Measured: At the end of the study (At 12 weeks, with window period of 2 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2019
- Study start3 Feb 2020
- Primary completion14 Jul 2022 (estimated)
- Study completion14 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Neuropathic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Viatris Korea
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04171453
- Sponsor's protocol ID
- A0081364
- Status last verified
- Jun 2022
- First submitted
- 10 Oct 2019
- Last updated
- 21 Jun 2022
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- POST-MARKETING SURVEILLANCE (PMS) TO OBSERVE THE SAFETY AND EFFECTIVENESS OF LYRICA(REGISTERED) CR EXTENDED RELEASE TABLETS
- ClinicalTrials.gov ID
- NCT04171453
- Acronym / sponsor ID
- A0081364
- Conditions
- Peripheral Neuropathic Pain
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Viatris KoreaIndustry (pharma, biotech, devices)
- Study start
- 3 Feb 2020 (actual)
- Primary completion
- 14 Jul 2022 (estimated)
- Study completion
- 14 Jul 2022 (estimated)
- First posted
- 21 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Open-label | – | Drug: Lyrica CR (Pregabalin)This study was open-label with only one treatment group. Lyrica CR was prescribed in accordance with usual clinical practice. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects administered with Lyrica CR as a part of routine treatment who comply with the local labeling.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lyrica CR (Pregabalin)Lyrica CR 82.5mg, 165mg, or 330mg OD | Drug | Open-label |
Primary outcome
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 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)
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 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 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 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.
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 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".
5 secondary outcomes
Severity of pain after administration of Lyrica CR
Time frame: At 12 weeks (window period of 2 weeks) or at the time of drug discontinuation.
Sleep interference status after administration of Lyrica CR
Time frame: At 12 weeks (window period of 2 weeks) or at the time of drug discontinuation.
Patient's Global Impression of Change (PGIC)
Time frame: At the end of the study (At 12 weeks, with window period of 2 weeks)
Clinician's Global Impression of Change
Time frame: At the end of the study (At 12 weeks, with window period of 2 weeks)
Final Effectiveness Evaluation
Time frame: At the end of the study (At 12 weeks, with window period of 2 weeks)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2022.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Neuropathic Pain, run by Viatris Korea at 3 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nam-Eun Kim (82-10-9310-7990, Nam-Eun.Kim@viatris.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2022.