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Safety And Efficacy 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: Neuralgia

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 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: Drug Use Investigation Of Lyrica(Regulatory Post Marketing Commitment Plan)

Study design: Observational Model: Case-Only, Time Perspective: Prospective

Primary outcome: Change in Clinical Global Impression of Clinical Condition (CGI-C) From Baseline at Month X

Detailed description: All the patients whom an investigator prescribes the first Lyrica« should be registered consecutively until the number of subjects reaches target number in order to extract patients enrolled into the investigation at random.

Eligibility

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Patients need to be administered Lyrica® 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: February 2011
Last updated: August 18, 2015

Page last updated: August 23, 2015

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