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) ScoreVAS 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
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