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

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

Completed

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Key information

Conditions

Post Herpetic Neuralgia DNA Virus Infections Herpes Zoster Herpesviridae Infections Infections Nervous System Diseases Neuralgia Neuralgia, Postherpetic Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Signs and Symptoms Varicella Zoster Virus Infection Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mobile, Alabama, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Change From Baseline to End of Study in LOCF VAS

Time frame: 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

Sponsors and collaborators

Lead sponsor

Depomed

Industry

Registry information

Official study title

A Phase 4, Open Label, Study of Safety and Effectiveness of GRALISE™(Gabapentin) Tablets in the Treatment of Patients With Postherpetic Neuralgia in Clinical Practice

Important dates

Study start: 2011
Primary completion: 2012
Study completion: 2012
First posted: Aug 31, 2011
Registry last updated: Mar 21, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed