DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017