Phase IV Study of FDA Approved, Once-Daily GRALISE™(Gabapentin) Tablets for the Treatment of Postherpetic Neuralgia

Completed

• Conditions: Post Herpetic Neuralgia

• Registration Number: NCT01426230
• Lead Sponsor: Depomed

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

Study Timeline

• Study First Submitted: 2011-08-29
• Study First Submitted QC: 2011-08-30
• Study First Posted: 2011-08-31
• Study Start: 2011-09
• Primary Completion: 2012-03
• Study Completion: 2012-04
• Results First Submitted: 2013-01-11
• Status Verified: 2013-03
• Results First Submitted QC: 2013-03-18
• Last Update Submitted: 2013-03-18
• Results First Posted: 2013-03-21
• Last Update Posted: 2013-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 201

Inclusion Criteria

• Men or Women 18 years or older who are suffering from PHN

Exclusion Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change From Baseline to End of Study in LOCF VAS	8 weeks (Baseline and Week 8)	Change from baseline in pain score on visual analog scale (VAS) (intensity scored from "No Pain" (0mm) to "Worst Possible Pain" (100mm)) at Week 8 of treatment; last observation carried forward (LOCF) analysis