A Post Marketing Surveillance Study On Pregabalin (Lyrica) On Efficacy, Safety And Tolerability Of Pregabalin
NCT00892008
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
- Male or female, 18 years old and above diagnosed with neuropathic pain.
- Patients that are pregnant and lactating; and patients with known hypersensitivity to
pregabalin or its related components.
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Descriptive Information | ||||
---|---|---|---|---|
Brief Title | A Post Marketing Surveillance Study On Pregabalin (Lyrica) On Efficacy, Safety And Tolerability Of Pregabalin | |||
Official Title | Pregabalin (Lyrica) Action In Neuropathic Pain Syndrome (PAINS): A Post Marketing Surveillance Study On Efficacy, Safety And Tolerability Of Pregabalin | |||
Brief Summary | This study is being conducted as a regulatory requirement post initial marketing authorization. This is primarily a safety study. This was an open label study and patients were enrolled once the decision to prescribe the medication was made by the Investigator. | |||
Detailed Description | Not Provided | |||
Study Type | Observational | |||
Study Design | Observational Model: Cohort Time Perspective: Prospective | |||
Target Follow-Up Duration | Not Provided | |||
Biospecimen | Not Provided | |||
Sampling Method | Non-Probability Sample | |||
Study Population | Male or female, 18 years and above diagnosed with neuropathic pain. | |||
Condition | Neuropathic Pain | |||
Intervention | Drug: Pregabalin
Pregabalin 75-150 mg BID for at least 2 weeks. Other Name: Lyrica | |||
Study Groups/Cohorts | Open-Label
This study was open-label with only one treatment group. Pregabalin was prescribed in accordance with usual clinical practice. Intervention: Drug: 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 | Completed | |||
Actual Enrollment | 2278 | |||
Original Actual Enrollment | 3000 | |||
Actual Study Completion Date | August 2008 | |||
Actual Primary Completion Date | August 2008 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
| |||
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 | Not Provided | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number | NCT00892008 | |||
Other Study ID Numbers | A0081094 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. ) | |||
Study Sponsor | Pfizer's Upjohn has merged with Mylan to form Viatris Inc. | |||
Collaborators | Not Provided | |||
Investigators |
| |||
PRS Account | Pfizer | |||
Verification Date | January 2010 |