Post-marketing Surveillance (PMS) to Observe the Safety and Effectiveness of Lyrica CR Extended Release Tablets
NCT04171453
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
Adult Trials: 18+ Years
]
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.
[
]
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.
NEED INFO?
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative
TRY A NEW SEARCH
Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Based on your search, you may also be interested in
- Soeul,
| 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 | 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:
[Exclusion criteria] Patients meeting any of the following criteria will not be included in the study:
| ||||||
| Sex/Gender |
| ||||||
| 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 |
| ||||||
| IPD Sharing Statement |
| ||||||
| Responsible Party | Pfizer | ||||||
| Study Sponsor | Pfizer | ||||||
| Collaborators | Not Provided | ||||||
| Investigators |
| ||||||
| PRS Account | Pfizer | ||||||
| Verification Date | February 2020 | ||||||