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A Post Marketing Surveillance Study On Pregabalin (Lyrica) On Efficacy, Safety And Tolerability Of Pregabalin

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 (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

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.

Clinical Details

Official title: Pregabalin (Lyrica) Action In Neuropathic Pain Syndrome (PAINS): A Post Marketing Surveillance Study On Efficacy, Safety And Tolerability Of Pregabalin

Study design: Observational Model: Cohort, Time Perspective: Prospective

Primary outcome:

Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4)

Discontinuations Due to Adverse Events

Secondary outcome:

Change From Baseline in Visual Analogue Scale (VAS) Score

VAS Pain Score at Baseline (BL) and Second Visit

VAS Pain Score at Baseline and Final Visit

Physician's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits

Patient's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits

Physician's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit

Patient's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit

Physician's Clinical Global Impression (CGI) on Tolerability at Second and Final Viist

Patient's Clinical Global Impression (CGI) of Tolerability at Second and Final Visit

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Male or female, 18 years old and above diagnosed with neuropathic pain.

Exclusion Criteria:

- Patients that are pregnant and lactating; and patients with known hypersensitivity to

pregabalin or its related components.

Locations and Contacts

Additional Information

To obtain contact information for a study center near you, click here.

Starting date: September 2006
Last updated: January 8, 2010

Page last updated: August 23, 2015

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