Safety And Efficacy In Long Term Use Of Lyrica (Regulatory Post Marketing Commitment Plan)
Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Neuropathic Pain
Intervention: Pregabalin (Lyrica) capsule (Drug)
Phase: N/A
Status: Active, not recruiting
Sponsored by: Pfizer Official(s) and/or principal investigator(s): Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer
Summary
The objective of this investigation is to evaluate the safety and efficacy of long term use
with Lyrica in medical practice. Also, occurrence of unknown and known adverse drug
reactions (ADRs) in subjects treated with Lyrica will be monitored during the survey period,
and whether an additional treatment outcome investigation and/or a post-marketing clinical
study is required in the future will be determined.
Clinical Details
Official title: Special Investigation Of Long Term Use Of Lyrica(Regulatory Post Marketing Commitment Plan)
Study design: Observational Model: Case-Only, Time Perspective: Prospective
Primary outcome: Number of Participants with Change from Baseline in Clinical Global Impression of Clinical Condition (CGI-C) at Month X
Detailed description:
Patients who fulfill criteria below:
1. Patients who have previously enrolled in A0081261.
2. Patients who have been administered Lyrica for more than 52 weeks.
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patients need to be administered by Lyrica for over 52 weeks in order to be enrolled
in the surveillance.
Exclusion Criteria:
- Patients not administered Lyrica.
Locations and Contacts
Additional Information
To obtain contact information for a study center near you, click here.
Starting date: August 2011
Last updated: August 18, 2015
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