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

N/ACompletedNCT01426230

Depomed201 enrolled

Overview

Study objective is to assess the safety and effectiveness of once- daily GRALISE in clinical practice

Open Label, single arm, 2wk titration, 6 wk stable dosing, 8 wk of total treatment, 1wk dose tapering

Study Type

OBSERVATIONAL

Enrollment

201

Conditions

Post Herpetic Neuralgia

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (37)

Outcomes

Primary Outcomes

Change From Baseline to End of Study in LOCF VAS

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

Time frame: 8 weeks (Baseline and Week 8)

Data from ClinicalTrials.gov

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