Post-marketing Surveillance (PMS) to Observe the Safety and Effectiveness of Lyrica CR Extended Release Tablets

NCT04171453

Last updated date
Study Location
Pfiizer
Soeul, , , Korea, Republic of
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Peripheral Neuropathic Pain
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

]

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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

]


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.

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Peripheral Neuropathic PainPost-marketing Surveillance (PMS) to Observe the Safety and Effectiveness of Lyrica CR Extended Release Tablets
NCT04171453
  1. Soeul,
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Advanced Information
Descriptive Information
Brief Title 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
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Subjects administered with Lyrica CR as a part of routine treatment who comply with the local labeling.
Condition Peripheral Neuropathic Pain
Intervention Drug: Lyrica CR (Pregabalin)
Lyrica CR 82.5mg, 165mg, or 330mg OD
Study Groups/Cohorts Open-label
This study was open-label with only one treatment group. Lyrica CR was prescribed in accordance with usual clinical practice.
Intervention: Drug: Lyrica CR (Pregabalin)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Estimated Enrollment
 (submitted: November 19, 2019)
600
Original Estimated Enrollment Same as current
Estimated Study Completion Date April 18, 2022
Estimated Primary Completion Date April 18, 2022   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study:All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number NCT04171453
Other Study ID Numbers A0081364
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement
Plan to Share IPD:No
Plan Description: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/d….
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date February 2020