Status:
COMPLETED
Phase IV Study of FDA Approved, Once-Daily GRALISE™(Gabapentin) Tablets for the Treatment of Postherpetic Neuralgia
Lead Sponsor:
Depomed
Conditions:
Post Herpetic Neuralgia
Eligibility:
All Genders
18+ years
Brief Summary
Study objective is to assess the safety and effectiveness of once- daily GRALISE in clinical practice
Detailed Description
Open Label, single arm, 2wk titration, 6 wk stable dosing, 8 wk of total treatment, 1wk dose tapering
Eligibility Criteria
Inclusion
- Men or Women 18 years or older who are suffering from PHN
Exclusion
- Patient is Pregnant or a nursing mother
- Patient has hypersensitivity to gabapentin
- Patient has an estimated creatinine clearance of \<30 mL/min or is in hemodialysis
Key Trial Info
Start Date :
September 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
201 Patients enrolled
Trial Details
Trial ID
NCT01426230
Start Date
September 1 2011
End Date
April 1 2012
Last Update
March 21 2013
Active Locations (37)
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1
Mobile, Alabama, United States
2
Tuscaloosa, Alabama, United States
3
Phoenix, Arizona, United States
4
Sun City, Arizona, United States